[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-sclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-sclerosis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,417,0,25,[9,47,71,92,117,140,165,187,225,244,265,296,322,342,366,396,422,444,476,506,530,554,576,596,618],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053392","exercise-rehabilitation-program-in-ms-who-use-wheelchairs-as-a-primary-mobility-device-100053392",false,"NCT06410261","Exercise Rehabilitation Program in MS Who Use Wheelchairs as a Primary Mobility Device","Randomized Pilot Study Evaluating the Effect of a 6-Month Exercise Rehabilitation Program on Physical and Cognitive Function in Persons With MS Who Use Wheelchairs as a Primary Mobility Device","MSGH","Inclusion Criteria:\n\n* diagnosis of MS\n* age above 18 years\n* no relapse within last 30 days\n* use of wheelchair for mobility in the community\n* ability to walk at least 50 feet (or 65 steps) using an assistive device\n* low risk for contraindications of physical activity indicated by no more than a single \"yes\"\n* response on the Physical Activity Readiness Questionnaire (PAR-Q)\n* willingness to complete the assessments and undergo randomization\n\nExclusion Criteria:\n\n* no diagnosis of MS\n* less than 18 years of age\n* not relapse-free within the last 30 days\n* no use of wheelchair as primary mobility device\n* no ability to walk for at least 50 feet (or 65 steps)\n* high risk for contraindications based on more than a single \"yes\" response on the PAR-Q\n* not willing to complete the testing procedures and undergo randomization","ALL","18 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"NA","Approximately 50% of people with multiple sclerosis (MS) use a wheelchair within 30 years of the initial diagnosis. Wheelchair use in MS is often associated with fatigue as a consequence of muscle weakness. Indeed, fatigue, a prevalent consequence of MS, often becomes debilitating and exhausts energetic resources when carrying-out tasks of daily life and\u002For interacting with the community, as these require ambulatory mobility. This experience of excessive fatigue has its roots in muscle weakness and results in reliance on a wheelchair for mobility, and the dependency on a wheelchair may further reduce muscular strength, particularly of the lower extremities. We propose that wheelchair users with MS can increase muscular strength through a personalized exercise rehabilitation, and this in turn will improve ambulatory performance and possibly reduce fatigue. To date, no research has examined the effects of this specific exercise rehabilitation program (GH method) on physical function and other disease-related outcomes in persons with MS who use wheelchairs as a primary mobility device.",[28],"Multiple Sclerosis",[30,31,32,33],"Exercise","Rehabilitation","Physical function","Cognition","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2024-04-29",{"date":42,"type":22},"2027-07-31",{"name":44,"class":45},"University of Illinois at Chicago","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100053711","understanding-the-impact-of-meal-timing-on-neurological-health-in-adults-with-multiple-sclerosis-100053711","NCT07475377","Understanding the Impact of Meal Timing on Neurological Health in Adults With Multiple Sclerosis","Meal Time MS","Inclusion Criteria:\n\n* Diagnosed with relapsing remitting or secondary progressive multiple sclerosis (RRMS or SPMS)\n* If on disease modifying therapy (DMTs), stable for 6 months\n* If not on DMTs, no DMT usage within previous 6 months\n* BMI 18.5-50 kg\u002Fm2\n* Access to a smartphone\n* Responsible for personal eating schedule or able to have input into schedule\n\nExclusion Criteria:\n\n* Relapse within previous 30 days\n* Actively engaged in a weight loss program or unwilling to follow assigned eating schedule\n* Current use of GLP-1 or use within previous 3 months\n* Regularly fasts \\> 12 hours\u002Fday\n* Employed in night shift or rotating shift work\n* Unable to walk 25 feet with or without assistive device (EDSS \\> 6.5).\n* Current use of insulin or sulfonylurea agents\n* Pregnant or breastfeeding\n* Currently enrolled in another trial that would confound results (e.g., exercise studies or other diet studies)","64 Years",{"count":56,"type":22},22,[25],"The goal of this clinical trial is to learn if the time an individual eats each day impacts neurological health in people with multiple sclerosis. The main questions the investigators are asking are:\n\n1. Does meal timing affect biomarkers of neuronal health (neurofilament light chain \\[NfL\\] and BDNF) and inflammation (IL-6, IL-17, TNF-ɑ) in adults with MS.\n2. Does meal timing affect expression of circadian clock genes and genes associated with autophagy in adults with MS.\n\nParticipants will be instructed to start and stop eating at specific times each day based on their group assignment and their personal schedule. They will respond to prompts sent to them on their smartphone to record the times they start and stop eating each day.\n\nAs a secondary goal, the study will also explore the feasibility of including translocator protein (TSPO)-PET imaging of neuroinflammation in future clinical trials of TRE in people with MS. To accomplish this, imaging will be completed in a subset of 8 participants at the beginning and end of the study.",[28],[61,62,28],"Nutrition","Circadian","NOT_YET_RECRUITING",{"date":37,"type":38},{"date":66,"type":22},"2026-08-01",{"date":68,"type":22},"2027-12-31",{"name":70,"class":45},"University of Alabama at Birmingham",{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":46},"100053763","phase-3-alternate-pre-med-in-anti-cluster-of-differentiation-20-cd20-pilot-project-100053763","NCT07472413","Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project","Cetirizine Versus Diphenhydramine as a Pre-medication: Tolerability and Safety in Patients With MS Receiving Anti-Cluster of Differentiation 20 (CD20) Infusion Therapy","Inclusion Criteria:\n\n* Ages ≥18 years\n* Able to read and speak in English or Spanish\n* Able to and willing to give informed consent\n* Diagnosis of Multiple Sclerosis (MS)\n* Patients starting or currently receiving ocrelizumab, ublituximab, rituximab\n\nExclusion Criteria:\n\n* Adults unable or unwilling to consent\n* Patients younger than 18 years of age\n* Pregnant women\n* Known hypersensitivity to cetirizine or any of its ingredients or hydroxyzine\n* Moderate or severe renal impairment (creatinine clearance or 11-31 mL\u002Fmin or worse)\n* Patients with prior hypersensitivity reactions on additional preventative measures (e.g. H1 and H2\u002Fproton-pump inhibitor (PPI) the night prior to the infusion due to history of reactions)",{"count":79,"type":22},60,[81],"PHASE3","The purpose of this study is to assess and compare how well multiple sclerosis (MS) patients tolerate cetirizine versus diphenhydramine as a pre-medication before receiving anti-CD20 infusion therapy of ocrelizumab, ublituximab or rituximab. The study will also compare the safety of cetirizine versus diphenhydramine as a pre-medication for preventing infusion reactions in MS patients receiving anti-CD20 infusion therapy.",[28],"2026-07-09",{"date":37,"type":38},{"date":87,"type":22},"2026-09-01",{"date":89,"type":22},"2028-07-01",{"name":91,"class":45},"University of Miami",{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":46},"100429766","sonification-techniques-for-gait-training-100429766","NCT04876339","Sonification Techniques for Gait Training","Sonification Techniques for Gait Training: a Pilot Multicentric Randomized Controlled Trial","SonicWalk","Inclusion criteria (stroke patients)\n\n* Age \\\u003C 80\n* Mini Mental State Examination \\> 24\n* Modified Rankin Scale: 1-3\n* Single hemisphere lesion\n* Stabilized disease (\\> 6 months after the acute event)\n* Impairment in gait parameters (e.g. velocity, perceived fatigue etc)\n* Motor independence during walking (without orthotic devices and aids) but with pathological pattern (spasticity level: Ashworth \\\u003C 2)\n\nInclusion criteria (patients with Parkinson's disease)\n\n* Age \\\u003C 80\n* Mini Mental State Examination \\> 24\n* Unified Parkinson Disease Rating Scale score (Parte III): \\\u003C 28\n* Stabilized disease and drug therapy\n* Altered gait patterns\n* Motor independence during walking (without orthotic devices and aids) but with pathological pattern\n\nInclusion criteria (patients with multiple sclerosis):\n\n* Age \\\u003C 60\n* Mini Mental State Examination \\> 24\n* Expanded Disability Status Scale score: 3-5\n* Stabilized disease in the last 6 months (without relapse or disability progression)\n* Altered gait patterns (i.e., careening, slowing down, spasticity: Ashworth \\\u003C 2, etc.)\n* Motor independence during walking\n\nExclusion Criteria (stroke patients)\n\n* Multiple or bilateral lesions\n* Neglect\n* Equinism\n* Spasticity: Ashworth \\>2\n* Structured (non-elastic) Achilles tendon retraction\n* Neurotoxin in the 3 months prior to the study\n* Baclofen introduced or modified in the week before the start of the study\n* Previous or concurrent diseases disabling the lower limb functions\n* Rehabilitative treatments with music in the year before the study\n\nExclusion criteria (patients with Parkinson's disease):\n\n* Previous or concurrent diseases disabling the lower limb functions\n* Changes of drug therapy during the study\n* Rehabilitative treatments with music in the year before the study\n\nExclusion criteria (patients with multiple sclerosis):\n\n* Previous or concurrent diseases disabling the lower limb functions\n* Neurotoxin in the 3 months prior to the study\n* Baclofen introduced or modified in the week before the start of the study\n* Spasticity: Ashworth \\>2\n* Structured (non-elastic) Achilles tendon retraction\n* Rehabilitative treatments with music in the year before the study","80 Years",{"count":102,"type":22},120,[25],"Music therapy is widely used in relational and rehabilitation settings. In addition to Neurologic Music Therapy and other music-based techniques, \"sonification\" approaches were recently introduced in the field of rehabilitation. The \"sonification\" can be defined as a properly selected set of sonorous-music stimuli are associated with patient movements mapping. In fact, the auditory-motor feedback can replace damaged proprioceptive circuits with a consequent improvement of the rehabilitation process. Interventions with \"sonification\" facilitate sensorimotor learning, proprioception and movements planning and execution improving global motor parameters. This study proposes the use of musical auditory cues which includes the melodic-harmonic component of the music. This kind of sonification makes the feedback pleasant and predictable as well as potentially effective. The investigators propose to apply and assess the effectiveness of this kind of sonification on gait training and other secondary outcomes in stroke, Parkinson's disease and multiple sclerosis population. Also, the investigators will assess the impact of \"sonification\" on the level of fatigue perceived during the rehabilitation process and on the quality of life. The study is a multicenter randomized controlled trial and will involve 120 patients that will undergo standard motor rehabilitation or the same rehabilitation but with the sonification support. The interventions will be evaluated at the baseline, after 10 sessions, after 20 sessions and at follow-up (one month after the end of the treatment). The assessment will include functional, motor, fatigue and quality of life evaluations. The collected data will be statistically processed.",[106,107,28],"Parkinson Disease","Stroke","2026-07-01",{"date":110,"type":38},"2026-07-02",{"date":112,"type":38},"2021-01-18",{"date":114,"type":22},"2027-06-30",{"name":116,"class":45},"Istituti Clinici Scientifici Maugeri SpA",{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100631186","phase-2-targeting-agonists-of-glucagon-like-peptide-1-receptor-for-multiple-sclerosis-100631186","NCT07497399","Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis","Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (TAG-MS): A Phase 2, Randomized, Double-Blind, Parallel-Arm Study","TAG-MS","Inclusion Criteria:\n\n* Diagnosis of MS (2024 criteria); clinically stable on MS therapy for ≥12 months without relapse or new lesions on brain MRI\n* Aged 18-60 years\n* Body mass index ≥27.0 kg\u002Fm2\n\nExclusion Criteria:\n\n* No GLP-1RA or GIP\u002FGLP-1 RA in past year; no known hypersensitivity to medication class\n* No known Barrett's esophagus\u002Fgastroesophageal reflux disease, pancreatitis (including past), or gastroparesis\n* No personal\u002Ffamily history of medullary thyroid carcinoma or history of multiple endocrine neoplasia syndrome type 2\n* No chronic kidney disease (estimated glomerular filtration rate ≤50 mL\u002Fmin) in past year, type 1 diabetes, known diabetic retinopathy, use of insulin or insulin-inducing medications\\*, dipeptidyl peptidase IV inhibitors\\*\\*, or warfarin; current\u002Factive alcohol or illicit substance abuse\n* No concerns about candidacy of individual on part of person's neurologist or study team clinicians\n* Current or planned (next 2 years) pregnancy\u002Fbreastfeeding; if able to become pregnant, agree to reliable contraception (contraception requirements as discussed below)\\*\\*\\*\n\n  * currently-approved: Lispro, Aspart, Glulisine, Afrezza, Regular, Concentrated Regular, or Novolin, Velosulin, NPH, glargine, detemir, degludec, and premixed; approved secretagogues: sulphonylureas (e.g. glipizide (± metformin), glyburide (± metformin), glimepiride, pioglitazone\u002Fglimepiride) \\& meglitinide analogues (nateglinide and repaglinide); \\*\\* currently-approved:sitagliptin, saxagliptin, linagliptin, alogliptin \\*\\*\\*Contraception: Participants of childbearing potential (participant has a uterus and is pre-menopausal) must agree to use contraception, using either one method with a failure rate of \\\u003C1%\u002Fyear, or two methods of lesser effectiveness:\n\nContraceptive methods with a failure rate of \\\u003C 1% per year includes the following:\n\n* Combined (estrogen and progesterone containing) hormonal contraception (vaginal ring, birth control patch) or progesterone-only hormonal contraception (birth control injections, intrauterine device (IUD), or hormone-releasing implant), or copper IUD\n* Complete abstinence from sexual encounters with a person who has testes\n\nThose who do not wish to use one of the above methods of contraception must use two methods. Options include:\n\n* Oral hormonal contraception plus one barrier method during sexual encounter with a person who has testes (below). While typically oral hormonal contraception has a low failure rate, it is possible that the absorption of contraceptive pills taken by mouth will be impacted by the study drug and thus lower contraceptive effectiveness. Thus, people using pills as primary contraception must, during asexual encounter with a person who has testes, use a second form of barrier contraceptive (below) or must change to one of the other contraceptive methods listed above.\n* Two forms of barrier contraception during sexual encounter with a person who has testes. Examples of barrier contraceptive methods include the following:\n\n  * A condom with or without spermicide\n  * A cap, diaphragm, or sponge with or without spermicide\n\n    * Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.","60 Years",{"count":102,"type":22},[128],"PHASE2","The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).\n\nResearchers will compare outcomes from participants randomized to the study drug, versus participants randomized to placebo, to see if there are signs of slowed neurodegeneration (i.e., reduction in brain and retinal atrophy).",[28],"2026-06-30",{"date":108,"type":38},{"date":134,"type":38},"2026-04-28",{"date":136,"type":22},"2030-01",{"name":138,"class":45},"Johns Hopkins University",2,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":164},"100616326","phase-1-a-study-evaluating-the-safety-and-efficacy-of-kite-363-in-relapsedrefractory-autoimmune-neurologic-diseases-100616326","NCT07304154","A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed\u002FRefractory Autoimmune Neurologic Diseases","A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19\u002FCD20 CAR T-cell Therapy in Participants With Relapsed\u002FRefractory Autoimmune Neurologic Diseases","Key Inclusion Criteria:\n\n* Reproductive status-related eligibility and contraception requirements:\n\n  * Participants must agree to use protocol-specified method(s) of contraception where applicable\n\nInclusion Criteria for multiple sclerosis (MS):\n\nMS (Relapsing and progressive forms):\n\n* Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria\n\nRelapsing forms of MS (relapsing-remitting multiple sclerosis (RRMS), active secondary-progressive multiple sclerosis (aSPMS)):\n\n* Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high efficacy disease-modifying therapy (DMT) OR Inadequate response to previous therapies defined as intolerance to ≥ 2 DMTs due to side effects prohibiting the chronic use of the DMT.\n* Expanded Disability Status Scale (EDSS) 0 to 5.5\n\nProgressive forms of MS (primary-progressive multiple sclerosis (PPMS) and non-active secondary-progressive multiple sclerosis (naSPMS)):\n\n* Inadequate response to previous therapies is defined as evidence of disease progression within 12 months prior to screening despite standard of care therapy for naSPMS or despite ocrelizumab, where available, for PPMS\n* Absence of clinical relapses for at least 24 months\n* No evidence of Gadolinium enhancing (GadE+) on magnetic resonance imaging (MRI) brain at screening or baseline\n* EDSS of 3 to 6.5 who are ambulatory\n\nInclusion Criteria for myasthenia gravis (MG):\n\n* Documentation of autoantibodies against acetylcholine receptor (AChR), muscle-specific kinase (MuSK), or low-density lipoprotein receptor-related protein 4 (LRP4)\n* Diagnosis of MG with generalized weakness meeting criteria as defined by the Myasthenia Gravis Foundation of American (MGFA) classification of II- IV at screening\n* Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6 (\\> 50% of the total score due to non-ocular symptoms)\n* Quantitative Myasthenia Gravis (QMG) score ≥ 10\n* Inadequate response to previous therapies while taking at least 2 classes of immunosuppressants (ie, steroids, azathioprine (AZA), mycophenolate mofetil (MMF), intravenous immunoglobulin (IVIg), biologics (eg, rituximab, anti-neonatal fragment crystallizable (Fc) receptor (FcRN) class, and anti-complement class))\n* Thymectomy allowed if completed ≥ 12 months prior to screening\n\nInclusion Criteria for chronic inflammatory demyelinating polyneuropathy (CIDP):\n\n* Probable or definite CIDP as defined by the 2010 European Federation of Neurological Societies\u002FPeripheral Nerve Society (EFNS\u002FPNS) criteria, relapsing or progressive forms\n* CIDP Disease Activity Status (CDAS) score ≥ 3 at screening\n* Inflammatory neuropathy cause and treatment (INCAT) score ≥ 3\n* Inadequate response to previous therapies despite standard of care therapy (ie, steroids, IVIg, subcutaneous immunoglobulin (SCIg), plasmapheresis exchange (PLEX), rituximab, or anti FcRN) OR Unable to tolerate standard of care due to side effects with ongoing disease activity\n* Except for nodal\u002Fparanodal CIDP, historical documentation of objective improvement in the past 24 months while on IVIg, SCIg, PLEX, or anti-FcRN OR Historical documentation of objective disease worsening in the past 24 months when IVIg, SCIg, PLEX, or anti-FcRN has been reduced or interrupted\n\nKey Exclusion Criteria:\n\n* History or presence of central nervous system (CNS) or peripheral nervous system disorders before enrollment that may impact cognition, strength, or cause weakness\n* History of autologous or allogeneic stem cell transplant and\u002For organ transplant\n\nExclusion Criteria for MS:\n\n* Cohort 1 or 2; inability to complete 9-hole Peg Test (9-HPT) in \\\u003C 240 seconds and Timed 25 foot Walk (T25FW) \\\u003C 150 seconds\n* History of hypersensitivity to parenteral administration of gadolinium-based contrast agents\n* Any renal condition that would preclude the administration of gadolinium (for the relapsing forms of MS and progressive forms of MS)\n* Any contraindication to lumbar puncture (LP) (for the relapsing forms of MS and progressive forms of MS)\n\nExclusion Criteria for MG:\n\n* Current myasthenic crisis not effectively controlled within 2 weeks before enrollment\n* Thymectomy performed within 12 months of baseline\n\nExclusion Criteria for CIDP:\n\n* Pure sensory CIDP and focal CIDP\n* Polyneuropathy of other causes\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","75 Years",{"count":149,"type":22},52,[151],"PHASE1","This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed\u002Frefractory autoimmune neurologic diseases.\n\nThe primary objectives of this study are:\n\n* To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases\n* To determine the recommended dose for Phase 1b.\n* To evaluate the preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases.",[154,155,28],"Chronic Inflammatory Demyelinating Polyneuropathy","Myasthenia Gravis",{"date":108,"type":38},{"date":158,"type":38},"2026-04-10",{"date":160,"type":22},"2029-06",{"name":162,"class":163},"Kite, A Gilead Company","INDUSTRY",6,{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100598699","phase-2-a-study-to-assess-bioequivalence-of-two-subcutaneous-sc-formulations-of-ocrelizumab-in-participants-with-multiple-sclerosis-ms-100598699","NCT07074886","A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)","A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis","PORTAMENTO","Inclusion Criteria:\n\n* Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start\n* Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening\n\nExclusion Criteria:\n\n* Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening\n* Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons\n* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening\n* Immunocompromised state\n* Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies\n* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study\n* Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study\n* Lack of peripheral venous access\n* Previous treatment with cladribine, atacicept, and alemtuzumab\n* Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation\n* Any previous history of transplantation or anti-rejection therapy\n* Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)","65 Years",{"count":175,"type":22},182,[128],"The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.",[28],{"date":110,"type":38},{"date":181,"type":38},"2025-11-13",{"date":183,"type":22},"2030-10-30",{"name":185,"class":163},"Hoffmann-La Roche",56,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":125,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100533006","phase-1-a-study-to-evaluate-the-safety-tolerability-efficacy-and-drug-levels-of-cc-97540-in-participants-with-relapsing-forms-of-multiple-sclerosis-progressive-forms-of-multiple-sclerosis-or-refractory-myasthenia-gravis-mg-breakfree-2-100533006","NCT06220201","A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)","A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants With Autoimmune Neurological Diseases: Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS), or Refractory Myasthenia Gravis (MG).","Inclusion Criteria\n\n\\- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1.\n\ni) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5.\n\nii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed\u002Frefractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months.\n\n\\- Progressive forms of MS - Cohort 2.\n\ni) Participants must have an EDSS ≥ 3.0 and ≤ 6.0.\n\nii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).\n\n\\- Myasthenia Gravis - Cohort 3\n\ni)MGFA classification of II-IV at screening\n\nii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening)\n\niii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics.\n\niv) Has had thymectomy, only if indicated according to current guidelines.\n\nExclusion Criteria\n\n* Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in \\\u003C240 seconds unless extenuating medical conditions unrelated to MS prohibit this.\n* Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in \\\u003C 150 seconds.\n* Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":102,"type":22},[151],"The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).",[28,155],[199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216],"CC-97540","CAR T","CART","NEX T","NEXT","BMS-986353","RMS","PMS","Multiple sclerosis","RRMS","aSPMS","PPMS","iSPMS","MG","gMG","refractory myasthenia gravis","general myasthenia gravis","CD19",{"date":108,"type":38},{"date":219,"type":38},"2024-03-28",{"date":221,"type":22},"2027-07-15",{"name":223,"class":163},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",35,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":173,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},"100493377","phase-1-a-study-to-investigate-the-safety-tolerability-and-processing-by-the-body-of-intravenous-and-subcutaneous-ro7121932-administration-in-participants-with-multiple-sclerosis-100493377","NCT05704361","A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis","A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3) Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1) and Subcutaneous Administration (Parts 2 and 3) in Participants With Multiple Sclerosis","Inclusion Criteria:\n\n* Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening\n* Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria)\n* Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up)\n* Female participants must practice abstinence or otherwise use contraception\n\nExclusion Criteria:\n\n* Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by \\>1 clinical relapse within 12 months prior to screening\n* Evidence of magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan\n* Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML\n* Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism\n* Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1\n* Participants with a current diagnosis of epilepsy\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases\n* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy \\>1 year prior to screening is not exclusionary\n* Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study\n* History of currently active primary or secondary (non-drug-related) immunodeficiency\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation\n* Only for cohorts where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure.\n\nPrior\u002FConcomitant Therapy:\n\n* Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial\n* Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab\n* Previous treatment with anti-cluster of differentiation 20 (CD20) B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)\n\n  * \\\u003C12 months prior to acquiring any screening laboratory tests,\n  * ≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baseline ± 20% (if data are available),\n  * If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons\n* Current or prior treatment with natalizumab (if \\\u003C24 months prior to acquiring any screening laboratory tests)\n\nPrior\u002FConcurrent Clinical Study Experience:\n\n\\- Participation in an investigational drug medicinal product or medical device study within 30 days before Screening or within five times the pharmacodynamic (PD) or pharmacokinetic (PK) half-life (if known), whichever is longer\n\nDiagnostic Assessments:\n\n* Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B\n* Participants with SI or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk\n* Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1",{"count":233,"type":22},129,[151],"The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).",[28],{"date":108,"type":38},{"date":239,"type":38},"2021-08-11",{"date":241,"type":22},"2027-07-08",{"name":185,"class":163},32,{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":173,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":46},"100631930","the-effect-of-internal--or-external-focused-exercise-training-administered-in-conjunction-with-a-cognitive-task-on-walking-balance-and-cognitive-functions-in-individuals-with-multiple-sclerosis-100631930","NCT07507084","The Effect of Internal- or External-Focused Exercise Training, Administered in Conjunction With a Cognitive Task, on Walking, Balance, and Cognitive Functions in Individuals With Multiple Sclerosis","Inclusion Criteria:\n\n* Diagnosis of Multiple Sclerosis according to the revised McDonald criteria\n* Aged between 20 and 60 years\n* Ability to understand and follow simple instructions\n* Ability to stand and walk independently or with an assistive device\n* Ability to speak and understand Turkish\n* Score of ≥21 on the Montreal Cognitive Assessment (MoCA)\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* MS relapse within the last 30 days\n* Presence of any other neurological disease besides Multiple Sclerosis\n* Any musculoskeletal condition that may affect walking or balance\n* History of uncontrolled cardiorespiratory conditions within the last 3 months (e.g., hypertension, arrhythmia, tachycardia, or acute cardiopulmonary events)\n* Severe visual or hearing impairment",{"count":251,"type":22},40,[25],"This interventional clinical trial aims to investigate the effects of internal and external focus-based exercise training combined with cognitive dual-task training in individuals diagnosed with multiple sclerosis. The primary objective is to determine whether these exercise approaches improve gait, balance, and cognitive functions.\n\nThe main research questions are:\n\nDoes dual-task training combined with internal focus-based exercises improve gait, balance, and cognitive performance? Does dual-task training combined with external focus-based exercises lead to greater improvements compared to internal focus strategies?\n\nParticipants will be divided into two groups, and the researchers will compare the effects of internal focus-based and external focus-based dual-task exercise training on functional outcomes.\n\nParticipants will:\n\nPerform structured exercise sessions under the supervision of a physiotherapist Engage in dual-task activities by combining motor exercises with simple cognitive tasks (e.g., backward counting, word generation) Participate in an 8-week training program, with sessions held twice a week lasting approximately 45-60 minutes Undergo assessments of gait, balance, and cognitive function before and after the intervention\n\nThis study does not involve invasive procedures or biological sample collection. The findings are expected to contribute to the development of more effective dual-task rehabilitation strategies for individuals with multiple sclerosis.",[28],[256],"multiple sclerosis, dual-task training, internal focus, external focus, gait, balance, cognitive function, exercise therapy","2026-06-29",{"date":108,"type":38},{"date":260,"type":38},"2026-03-15",{"date":262,"type":22},"2028-08-30",{"name":264,"class":45},"Kutahya Health Sciences University",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":272,"sex":18,"minAge":273,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":277,"phases":4,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":4,"leadSponsor":293,"locationsCount":46},"100117414","comprehensive-multimodal-analysis-of-neuroimmunological-diseases-of-the-central-nervous-system-100117414","NCT00794352","Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System","Comprehensive Multimodal Analysis of Patients With Neuroimmunological Diseases of the CNS","* PATIENT INCLUSION CRITERIA (for in-person and telemedicine sub-cohorts):\n\nPresentation with a clinical syndrome consistent with immune-mediated CNS disorder and\u002For\n\nNeuroimaging evidence of inflammatory and\u002For demyelinating\u002Fdysmyelinating CNS disease\n\nAt least 12 years old at the time of enrollment\n\nWilling to share medical records (including past MRI results) with the study team.\n\nAdults: Able to give informed consent on their own or via a Legally Authorized Representative (LAR) or Durable Power of Attorney (DPA); or Minors: parent or legal guardian able to give consent, with child willing to give assent, if reasonable based on their age and assent capacity\n\nFor in-person sub-cohort: Able to undergo the required procedures, including LP, MRI and clinical\u002Ffunctional evaluations\n\nPATIENT EXCLUSION CRITERIA (for in-person and telemedicine sub-cohorts):\n\nSignificant medical condition that would make participation in research part of evaluation impossible or risky\n\nFor in-person sub-cohort: Medical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)\n\nUnwilling to consent for collection of biological samples or their cryopreservation\n\nPATIENT INCLUSION CRITERIA for processing of collected biological samples:\n\nPresentation with a clinical syndrome consistent with immune-mediated CNS disorder and\u002For\n\nNeuroimaging evidence of inflammatory and\u002For demyelinating\u002F dysmyelinating CNS disease\n\nAbility to obtain either direct or surrogate informed consent for sample processing and storage\n\nAged 0+ years\n\nHEALTHY VOLUNTEER (in person) INCLUSION CRITERIA:\n\nAt least 18 years old at the time of enrollment\n\nVital signs are found within normal range at the time of the screening visit\n\nAble to give informed consent\n\nAble and willing to undergo related research procedures, such as blood draw, LP\n\nHEALTHY VOLUNTEER (in person) EXCLUSION CRITERIA:\n\nSystemic inflammatory disorder, or inflammatory or non-inflammatory neurological diseases\n\nPrevious or current history of alcohol and substance abuse\n\nMedical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)\n\nMedical contraindication for LP\n\nPsychological contraindications for MRI (i.e. claustrophobia). This will be assessed at the time the medical history is collected\n\nPregnancy or current breastfeeding\n\nAny contraindications to having study procedures done\n\nHistory of auditory disorder (i.e. hearing impairment, known impaired acoustic reflex, tinnitus)\n\nHEALTHY VOLUNTEER SUB-STUDY TO OBTAIN NORMATIVE DATA FOR THE SMARTPHONE APPS:\n\nBecause this sub-study collects no personal identifiable information (PII), there are no inclusion\u002Fexclusion criteria. Participating subjects are self-declared as not having any neurological deficit, which would be the same population that would provide normative data if the apps were freely available via App store.",true,"1 Month","99 Years",{"count":276,"type":22},2400,"OBSERVATIONAL","Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS). This study will compare tests performed on both healthy volunteers and individuals who have signs or symptoms of immune-related damage to their CNS.\n\nThis study will include two groups of subjects at least 12 years old. Subjects will either have symptoms of immune-related CNS damage, or will be healthy volunteers selected for comparison purposes.\n\nStudy participants will visit the NIH Clinical Center on an outpatient basis for an initial evaluation visit. During the visit, patients will provide a comprehensive medical history and undergo a neurological examination, and will provide blood samples for research purposes. The healthy volunteers will be asked to schedule a return visit for a magnetic resonance imaging (MRI) procedure, and may be asked to undergo other tests requested by the study researchers on an as-needed basis. The group of patients with symptoms of immune-related CNS damage will be asked to undergo a series of tests, including the following:\n\n* MRI procedures, with a minimum of three brain MRIs and one spinal cord MRI taken approximately 4 weeks apart\n* A diagnostic lumbar puncture, performed on an outpatient basis\n* Tests of brain and vision activity\n* Additional blood and tissue samples\n\nPatients with symptoms of immune-related CNS damage may be offered the opportunity to participate in additional followup tests with NIH researchers.\n\n...",[280,28],"Central Nervous System Disease",[282,28,283,284,285,286,280,287,288],"Inflammation","Neuroimmunology","Immune Disorder","Neuroimaging","Natural History","Healthy Volunteers","HV","2026-06-27",{"date":131,"type":38},{"date":292,"type":38},"2008-10-01",{"name":294,"class":295},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":173,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":4},"100644698","inspiratory-muscle-training-in-individuals-with-multiple-sclerosis-100644698","NCT07672535","Inspiratory Muscle Training in Individuals With Multiple Sclerosis","Comparison of the Effects of High-Intensity and Low-Intensity Inspiratory Muscle Training in Individuals With Multiple Sclerosis","Inclusion Criteria:\n\n* Diagnosis of multiple sclerosis (MS) according to the 2024 McDonald criteria\n* Expanded Disability Status Scale (EDSS) score ≥2 and \\\u003C6\n* Age between 18 and 65 years\n* Mini-Mental State Examination (MMSE) score \\>24\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Experiencing an MS relapse within the past three months\n* Presence of chronic cardiac or pulmonary diseases that may affect respiratory muscle strength and function, such as COPD, asthma, interstitial lung disease, or heart failure\n* Presence of pulmonary infection\n* Presence of orthopedic problems\n* Presence of psychiatric disorders\n* Pregnancy",{"count":304,"type":22},48,[25],"Multiple sclerosis (MS) is a chronic disease affecting the central nervous system, characterized by inflammation, demyelination, and axonal degeneration, and primarily affects young adults. Muscle weakness, sensory disturbances, spasticity, pain, visual impairment, ataxia, fatigue, cognitive dysfunction, and respiratory complications are among the most commonly reported symptoms in individuals with MS. Although inspiratory muscle training has been shown to have beneficial effects in individuals with MS, the effects of different inspiratory muscle training intensities on respiratory muscle strength and pulmonary function have not been sufficiently investigated.\n\nThe primary aim of this study is to investigate the effectiveness and clinical feasibility of high-intensity interval inspiratory muscle training in individuals with MS. The secondary aim is to compare the effects of high-intensity interval inspiratory muscle training, low-intensity inspiratory muscle training, and conventional rehabilitation on respiratory muscle strength, pulmonary function, cough effectiveness, exercise capacity, lower extremity functional muscle strength, balance, fatigue, dysphagia severity, sleep quality, and quality of life in individuals with MS.\n\nParticipants will be randomly assigned to one of three groups: a high-intensity interval inspiratory muscle training group, a low-intensity inspiratory muscle training group, or a conventional rehabilitation group. All three groups will receive conventional rehabilitation, while the inspiratory muscle training groups will additionally receive their respective inspiratory muscle training programs. This study aims to be the first randomized controlled trial to evaluate the effects of high-intensity interval inspiratory muscle training in individuals with MS.",[28,308],"Inspiratory Muscle Training",[310,311,312,313],"multiple sclerosis","inspiratory muscle training","respiratory muscle training","respiratory muscle strength","2026-06-26",{"date":257,"type":38},{"date":317,"type":22},"2026-08",{"date":319,"type":22},"2028-01",{"name":321,"class":45},"Istanbul University - Cerrahpasa",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":147,"enrollmentInfo":328,"targetDuration":4,"studyType":277,"phases":4,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":338,"leadSponsor":340,"locationsCount":46},"100645151","the-mediating-role-of-balance-in-the-relationship-between-fatigue-and-fear-of-falling-in-individuals-with-multiple-sclerosis-100645151","NCT07680049","The Mediating Role of Balance in the Relationship Between Fatigue and Fear of Falling in Individuals With Multiple Sclerosis","Inclusion Criteria:\n\n* Age 18-65 years\n* Neurologist-confirmed MS diagnosis\n* No relapse within the previous 30 days\n* Ability to walk independently or with an assistive device\n* Ability to understand instructions\n* Voluntary participation\n\nExclusion Criteria:\n\n* Recent MS relapse\n* Severe vestibular disorder\n* Other neurological diseases\n* Severe orthopedic conditions affecting mobility\n* Recent lower extremity surgery or trauma\n* Cardiopulmonary conditions limiting assessment",{"count":251,"type":22},"Fatigue, balance impairment, and fear of falling are common problems in individuals with Multiple Sclerosis (MS). Previous studies have shown significant associations among these variables; however, the mechanisms underlying the relationship between fatigue and fear of falling remain unclear. It is possible that fatigue increases fear of falling indirectly through its negative effects on balance performance.",[28],[332,28,333,334],"Fatigue","Postural Balance","Fear","2026-06-25",{"date":108,"type":38},{"date":108,"type":22},{"date":339,"type":22},"2026-07-25",{"name":341,"class":45},"Uskudar University",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":173,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":46},"100585386","phase-2-home-based-transcranial-direct-current-stimulation-tdcs-for-depression-in-multiple-sclerosis-ms-100585386","NCT06901687","Home-Based Transcranial Direct Current Stimulation (tDCS) for Depression in Multiple Sclerosis (MS)","Home-Based tDCS for Depression in Multiple Sclerosis: A Randomized Sham-Controlled Trial","Inclusion Criteria:\n\n* Age: 18-65 years (inclusive)\n* Diagnosis: Confirmed diagnosis of multiple sclerosis (MS), including relapsing-remitting or secondary progressive subtypes\n* Stable Medications: Stable use of antidepressant and disease-modifying therapies (DMTs) for at least 30 days prior to enrollment\n* Stable Disease Activity: Defined as no clinical relapse, no new radiological disease activity, and no recent steroid treatment for at least 30 days prior to enrollment\n* Provider Contact: Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms\n* Technical Ability: Ability to use mobile devices and participate in remote, video-supervised sessions\n\nExclusion Criteria:\n\n* Neurological or Medical Disorders: History of primary neurological disorder other than MS (e.g., stroke, Parkinson's disease, traumatic brain injury (TBI), intracranial mass, epilepsy, mild cognitive impairment (MCI), dementia), major psychiatric disorders (e.g., bipolar disorder, psychotic disorders), or serious medical conditions (e.g., myocardial infarction, thyroid disease, diabetes with complications, atrial fibrillation)\n* Substance Use: Nicotine use (e.g., smoking or vaping) within the past 6 months\n* Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding. If able to become pregnant, participants will be required to use medically accepted birth control methods, including hormonal methods (e.g., pills, patches, implants), barrier methods (e.g., condoms or diaphragm with spermicide), intrauterine device (IUD), or abstinence. Participants will be advised not to become pregnant during the study.\n* Seizure History: History of seizures or seizure disorder within the past 5 years\n* Implanted Devices or Metal Objects: Presence of metal in the head\u002Fneck area (excluding dental fillings) or implanted medical devices (e.g., neurostimulators, pacemakers, defibrillators)\n* Skin Conditions: Active skin disorders or skin sensitivity near electrode application sites",{"count":350,"type":22},170,[128],"This project is a double-blind, sham-controlled, parallel-arm, randomized controlled trial. We will recruit n=170 people living with MS, who are experiencing an episode of depression in the context of a major depressive episode (MDE). Using our remotely supervised (RS) tDCS protocol, enrolled participants will complete 30 days of 30-minute tDCS (2.0, DLPFC left anodal) while listening to mindfulness meditation. Over the course of the study, participants will complete assessments of depression and MS symptoms. Participants will be randomized 1:1 active:sham tDCS.",[28,354],"Depression",[28,354,356,357,358],"Neuromodulation","Home-Based","transcranial direct current stimulation",{"date":257,"type":38},{"date":361,"type":38},"2025-08-11",{"date":363,"type":22},"2028-06-01",{"name":365,"class":45},"NYU Langone Health",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":372,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":374,"maxAge":375,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":164},"100399412","phase-4-safety-and-efficacy-study-of-fingolimod-in-taiwanese-adults--20years-with-relapsing-remitting-multiple-sclerosis-100399412","NCT04480853","Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis","A 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING)","SPRING","Inclusion Criteria:\n\n-Patients with relapsing-remitting multiple sclerosis that are fingolimod treatment naive at the time of study entry and are newly starting fingolimod based on physician judgement and according to Taiwan's fingolimod package insert (version TWI-090420)\n\nExclusion Criteria:\n\n* Patients with the diagnosis of neuromyelitis optica.\n* Patients who are being treated with any investigational drug at the time of study entry.\n* In the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or Class III\u002FIV heart failure\n* A history or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient has a functioning pacemaker\n* A baseline QTc interval ≥ 500 msec\n* Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs\n* Patient with known immune deficiency, increased risk of opportunistic infection, severe active infection or chronic active infection.\n* Patients with severe active malignancies, except for basal cell epithelioma\n* Patients with severe hepatic insufficiency\n* Pregnant or nursing (lactating) women or women of childbearing potential unless on contraception","20 Years","100 Years",{"count":377,"type":22},30,[379],"PHASE4","The purpose of the study is to describe the safety profile of fingolimod in the Taiwanese multiple sclerosis population. This study aims to collect the safety data in patients newly initiated on fingolimod for one year.",[28],[383,207,384,385,386,387,388],"Fingolimod","Relapsing-remitting multiple sclerosis","Relapsing-remitting","Post-authorization study","Adult","MS",{"date":314,"type":38},{"date":391,"type":38},"2020-10-12",{"date":393,"type":22},"2027-09-30",{"name":395,"class":163},"Novartis Pharmaceuticals",{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":403,"enrollmentInfo":404,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":46},"100269228","phase-2-effect-of-corticosteroids-on-inflammation-at-the-edge-of-acute-multiple-sclerosis-plaques-100269228","NCT02784210","Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques","The Effect of Corticosteroids on Inflammation at the Edge of Acute Multiple Sclerosis Plaques: An Investigator-Blinded Study","* INCLUSION CRITERIA:\n* Multiple sclerosis, as defined by the 2017 Revised McDonald Criteria;\n* Age 18 or older;\n* Ability to provide informed consent;\n* Able to participate in study procedures and provide high-quality clinical research and imaging data, based on limited artifacts on prior MRI scans and, when possible to determine;\n* Presence of a gadolinium enhancing lesion on the screening (3T or 7T) brain MRI that demonstrates either centripetal\u002Frim enhancement or a phase rim, or both;\n* Simultaneously participates in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry.\n* Willing to use birth control if able to conceive a child\n\nEXCLUSION CRITERIA:\n\n* Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed);\n* Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected;\n* Treatment with systemic steroids in previous 30 days (non-systemic administration of steroids, such as topical or local injection, is acceptable);\n* Experiencing new neurological symptoms, with onset in previous 2 weeks, attributable to MS relapse;\n* Pregnancy or current breastfeeding;\n* Screening labs, only if required per current NIH Clinical Center guidelines for kidney-function screening before gadolinium-based MRI contrast, demonstrating estimated glomerular filtration rate \\\u003C60 mL\u002Fmin;\n* Known hypersensitivity to gadolinium-based contrast agents;\n* Medical contraindications to corticosteroid administration (e.g., diabetes, gastric ulcer)","120 Years",{"count":377,"type":22},[128],"Background:\n\nMultiple sclerosis (MS) affects the brain, spinal cord, and optic nerves. MS lesions can appear on the MRI (magnetic resonance imaging) scans in many ways. Sometimes they light up from the outer edge and fill inward. This is called ring enhancement. Researchers think this type of lesion may not heal as well as others. Corticosteroids are the standard treatment to reduce symptoms of MS relapse. But there is no standard treatment for people with enhancing MS lesions without signs of MS relapse. Researchers want to see if a short-term high-dose course of corticosteroids helps heal those lesions.\n\nObjective:\n\nTo study the effects of short-term high-dose corticosteroids on ring-enhancing MS.\n\nEligibility:\n\nAdults ages 18 and older who:\n\n* Have MS and a rim-enhancing lesion on a prior brain MRI\n* Are enrolled in another NINDS protocol\n\nDesign:\n\nParticipants will be screened under another protocol\n\nParticipants will be randomly assigned to get either no treatment or 3 days of treatment with a corticosteroid.\n\nParticipants will have:\n\n* 1 baseline visit\n* 3 days of high-dose steroids, intravenous or oral. If IV, participants will receive methylprednisolone by IV each day. Participants will also be prescribed medicine to protect their stomach.\n* Follow-up visits will be at week 13 and week 25 after randomization to treatment or no treatment.\n\nVisits include medical history and physical exam. Participants will have blood and urine tests. Participants will also have neurological exams and MRIs. Participants lie on a table that slides into a cylinder. They are in the scanner 1.5-2 hours. They get a dye through a catheter: A needle guides a thin plastic tube into an arm vein.",[28],[409,410,411,412,388],"Centripetal Enhancement","MRI","7 Tesla","Gadolinium","2026-06-23",{"date":415,"type":38},"2026-06-24",{"date":417,"type":38},"2016-10-05",{"date":419,"type":22},"2028-12-31",{"name":421,"class":295},"National Institute of Neurological Disorders and Stroke (NINDS)",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":125,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":443},"100617951","phase-3-non-inferiority-study-of-frexalimab-subcutaneous-administration-compared-to-intravenous-administration-in-adult-participants-with-multiple-sclerosis-100617951","NCT07325292","Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis","A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis","Frexcite","Inclusion Criteria:\n\nThe participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group:\n\nGroup A (RMS)\n\n* The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.\n* The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria.\n* The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).\n* The participant must have at least 1 of the following prior to screening:\n\n  * 1 documented relapse within the previous year OR\n  * 2 documented relapses within the previous 2 years, OR\n  * 1 documented Gd enhancing lesion on an MRI scan within the previous year. Group B (nrSPMS)\n* Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria\n* The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.\n* The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.\n* The participant must have documented evidence of disability progression observed during the 12 months before screening.\n* The participant must have an absence of clinical relapses for at least 24 months.\n* The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit).\n\nParticipants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply:\n\n\\- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.\n* The participant has a history of infection or may be at risk for infection:\n* Fever within 28 days of the Screening Visit\n* Presence of psychiatric disturbance or substance abuse\n* History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and\u002For antiphospholipid syndrome and any participants requiring antithrombotic treatment.\n* Current hypogammaglobulinemia defined by Ig levels (IgG and\u002For IgM) below the LLN at screening or a history of primary hypogammaglobulinemia.\n* A history or presence of disease that can mimic MS symptoms.\n* The participant has a contraindication for MRI.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":431,"type":22},160,[81],"This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment.\n\nThe purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.\n\nStudy details include:\n\nThe study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months.\n\nThe number of scheduled visits (Parts A and B) will be 17 or 11 for participants receiving frexalimab SC or IV, respectively, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.",[28],"2026-06-22",{"date":413,"type":38},{"date":438,"type":38},"2026-01-14",{"date":440,"type":22},"2028-11-30",{"name":442,"class":163},"Sanofi",34,{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":277,"phases":4,"briefSummary":453,"conditions":454,"keywords":462,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":139},"100637471","balance-gait-and-motion-analysis-in-multiple-sclerosis-100637471","NCT07630311","\"Balance, Gait, and Motion Analysis in Multiple Sclerosis\"","\"Functional Assessment of Balance and Gait and Correlation With Kinetic and Kinematic Parameters in Patients With Multiple Sclerosis: Cross-Sectional Study\"","MS-BALGAIT","Inclusion Criteria:\n\n* Adults (≥ 18 years) with confirmed diagnosis of Multiple Sclerosis\n* Expanded Disability Status Scale (EDSS) score \\\u003C6\n* Ability to ambulate independently without the use of assistive devices\n* Absence of significant orthopedic or neurological conditions affecting mobility\n* Ability to understand and follow verbal instructions.\n\nExclusion Criteria:\n\n* History of injury or surgical intervention to the lower limbs or spine within the past year\n* Any musculoskeletal, neurological, cardiovascular, or other medical condition, other than Multiple Sclerosis, that may significantly affect gait or balance or compromise participant safety during testing.\n* Severe balance impairment or high risk of falling that prevents safe participation in single-leg stance, gait analysis, or obstacle negotiation tasks.",{"count":251,"type":22},"The goal of this observational cross-sectional study is to investigate the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS).\n\nThe main questions it aims to answer are:\n\ni) What is the relationship between kinetic and kinematic gait and balance parameters measured using the Vicon motion analysis system and performance on clinical functional assessments in people with Multiple Sclerosis?\n\nii) Which biomechanical parameters are most strongly associated with functional balance, gait, and physical performance outcomes?\n\nParticipants will attend a single laboratory-based assessment session. During this session, they will undergo biomechanical gait and balance analysis using the Vicon motion capture system, complete functional assessments of balance, gait, and physical performance, complete questionnaires assessing fear of falling and fatigue, and undergo assessment of lower-limb spasticity.",[28,455,333,456,457,458,459,460,332,461],"Gait Disorders, Neurologic","Motion Analysis","Biomechanics","Kinetics","Kinematics","Physiotherapy","Fall",[28,463,464,456,465,466,467,332,457],"Balance","Gait","Vicon System","Functional Assessments","Physical Performance","2026-06-21",{"date":415,"type":38},{"date":471,"type":38},"2025-09-01",{"date":473,"type":22},"2026-08-30",{"name":475,"class":45},"University of Patras",{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":173,"enrollmentInfo":484,"targetDuration":4,"studyType":23,"phases":486,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":502,"leadSponsor":504,"locationsCount":46},"100644082","comprehensive-rehabilitation-programme-in-people-with-multiple-sclerosis-the-reconnect-ms-study-100644082","NCT07666958","Comprehensive Rehabilitation Programme in People With Multiple Sclerosis: The RECONNECT-MS Study","Effect of Specialised Physiotherapy and Supportive Psychotherapy on Clinical Status, Neuroplasticity, and Quality of Life in People With Multiple Sclerosis: A Prospective Interventional Study With a Self-Controlled Design","RECONNECT-MS","Inclusion Criteria:\n\n* Unambiguous clinical diagnosis of multiple sclerosis (any subtype, including relapsing-remitting, secondary progressive, and primary progressive)\n* Age 18-65 years\n* Predominantly motor disability with Expanded Disability Status Scale (EDSS) 2-6\n* No relapse within the past month\n* Able to attend outpatient physiotherapy regularly and motivated to participate in the programme\n* Able and willing to complete 3 sets of clinical examinations and 3 MRI examinations\n\nExclusion Criteria:\n\n* Conditions impairing mobility (e.g., severe injuries, orthopaedic problems, other neurological conditions)\n* Acute inflammatory conditions or infections at the time of programme initiation that could affect the results or safety of the participant\n* Change or planned change of treatment (including disease-modifying therapy or corticosteroid therapy) within the past month or during the programme\n* Contraindications to MRI examination (e.g., first-trimester pregnancy, presence of a pacemaker, defibrillator, older metallic joint replacements, or other metallic implants)\n* Long-term planned absence during the programme (e.g., holiday, surgical procedure)",{"count":485,"type":22},45,[25],"The goal of this clinical trial is to learn if a comprehensive rehabilitation programme can improve physical function, reduce fatigue, and raise quality of life in adults aged 18-65 with multiple sclerosis (MS). The study will also look at whether the programme leads to changes in brain function using magnetic resonance imaging (MRI). The main questions it aims to answer are:\n\n* Does the programme lower the overall impact of MS on daily life?\n* Does the programme improve walking, balance, and hand function?\n* Does the programme reduce the impact of fatigue?\n* Are there changes in brain connections after the programme?\n\nEach participant serves as their own comparison. They are tested 3 times: 2 months before the programme starts (T0), right before it starts (T1), and after 2 months of intensive treatment (T2). The period between T0 and T1, when no treatment is given, shows each person's natural changes over time.\n\nParticipants will:\n\n* Attend individual physiotherapy twice a week for 2 months, then 3 follow-up sessions over the next month\n* Take part in 3 group movement-awareness sessions\n* Take part in 3 group psychotherapy sessions focused on stress management and relaxation\n* Receive written nutritional guidance for autoimmune conditions\n\nTests include physical assessments, questionnaires about fatigue and quality of life, tremor measurement, and brain MRI scans.\n\nThe results may help improve rehabilitation care for people with MS and support their ability to stay active in everyday and working life.",[28],[28,31,460,490,491,492,493,332,494,495,496,497,498],"Psychotherapy","Neuroplasticity","Functional Magnetic Resonance Imaging","Quality of Life","Self-Controlled Design","Comprehensive Care","Motor Programme Activating Therapy","Physical Therapy Modalities","Neurological Rehabilitation","2026-06-19",{"date":415,"type":38},{"date":108,"type":22},{"date":503,"type":22},"2028-06-30",{"name":505,"class":45},"Charles University, Czech Republic",{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":173,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":529},"100643908","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-immunogenicity-and-pharmacodynamics-of-a-new-subcutaneous-formulation-of-ocrelizumab-in-participants-with-multiple-sclerosis-100643908","NCT07667322","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a New Subcutaneous Formulation of Ocrelizumab in Participants With Multiple Sclerosis","A Phase 1b Multicenter, Non-randomized, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Single Ascending Doses of a New Subcutaneous Formulation of Ocrelizumab in Patients With Multiple Sclerosis","OCARINA 3","Inclusion Criteria:\n\n* Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)\n* Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening\n\nExclusion Criteria:\n\n* Participants who have previously received anti-cluster of differentiation 20 (CD20s) (including ocrelizumab) less than 2 years before screening\n* Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening\n* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening\n* Immunocompromised state\n* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study\n* Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study\n* Lack of peripheral venous access\n* Previous treatment with cladribine, atacicept, and alemtuzumab\n* Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline\n* Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation\n* Any previous history of transplantation or anti-rejection therapy\n* Positive screening tests for active, latent, or inadequately treated hepatitis B\n* Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab",{"count":515,"type":22},75,[151],"The main purpose of this study is to evaluate the safety and tolerability of the ocrelizumab subcutaneous (SC) test formulation in participants with multiple sclerosis (MS). The study consists of two treatment phases: a dose-escalation and dose-continuation phase. Participants will receive single ascending doses of ocrelizumab SC during an initial dose-escalation phase, with the option to continue treatment with the selected dose of ocrelizumab SC in the dose-continuation phase.",[28],[520,521],"Relapsing Remitting Multiple Sclerosis","Primary Progressive Multiple Sclerosis","2026-06-18",{"date":335,"type":38},{"date":525,"type":38},"2024-12-17",{"date":527,"type":22},"2028-08-01",{"name":185,"class":163},12,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":541,"briefSummary":542,"conditions":543,"keywords":544,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":553},"100461227","phase-4-ocrelizumab-discontinuation-in-relapsing-multiple-sclerosis-100461227","NCT05285891","Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis","Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05)","AMS05","Inclusion Criteria:\n\n1. Have at least one clinical episode that satisfies McDonald 2017 criteria for early Multiple sclerosis (MS) with a dissemination in time that can be met clinically, by Magnetic Resonance Imaging (MRI), or based on oligoclonal band (OCB) positivity\n2. Have a length of disease duration, from first symptom, of ≤ 3 years at time of informed consent\n3. For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use effective methods of contraception during the treatment period and for at least 6 months after the last dose of study drug:\n\n   1. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus)\n   2. Examples of contraceptive methods include bilateral tubal ligation, male sterilization, established hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices, and copper intrauterine devices\n   3. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception\n   4. Barrier methods must always be supplemented with the use of a spermicide\n\nExclusion Criteria:\n\n1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n2. History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)\n3. Any metallic material or electronic device in the body, or condition that precludes the participant from undergoing MRI\n4. Known presence or history of other neurological disorders, including but not limited to the following:\n\n   * Ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage\n   * CNS or spinal cord tumor, metabolic or infectious cause of myelopathy, genetically inherited progressive CNS disorder, CNS sarcoidosis, or systemic autoimmune disorders potentially causing progressive neurologic disease or affecting ability to perform the study assessments\n5. Pregnancy or lactation\n\n   • Female participants of childbearing potential must have a negative urine pregnancy test at screening\n6. Any concomitant disease that may require chronic systemic treatment with corticosteroids or immunosuppressants during the course of the study\n7. Lack of peripheral venous access\n8. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies\n9. Significant, inadequately controlled (e.g., diagnostic evaluations indicated or change in medications warranted) disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine, and gastrointestinal or any other significant disease that in the opinion of the investigator may preclude participant from participating in the study\n10. Functional status of New York Heart Association (NYHA) Class III or higher for heart failure at the screening visit\n11. Known active bacterial, viral, fungal, mycobacterial infection or other infection (including tuberculosis (TB) or atypical mycobacterial disease but excluding limited superficial fungal or viral infections of the skin or nails) or any severe episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to Mo 0\u002FDay 0 infusion or oral antibiotics within 2 weeks prior to Mo 0\u002FDay 0 infusion\n12. Active or chronic infection with human immunodeficiency virus (HIV), syphilis or TB (see laboratory tests below)\n13. Evidence of past hepatitis B (including treated hepatitis B) or untreated hepatitis C infection (treated hepatitis C is not considered exclusionary). Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection (see laboratory tests below).\n14. Known active malignancy or active monitoring for recurrence of malignancy, including solid tumors and hematological malignancies, except basal cell, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix or the uterus that have been excised with clear margins\n15. Substance use disorder, including the recurrent use of alcohol and\u002For drugs within the past year associated with clinically significant impairment associated with failure to meet major responsibilities at work, school, or home\n16. Receipt of live or live-attenuated vaccines within 4 weeks prior to Mo 0\u002FDay 0 infusion\n17. Contraindications to or severe intolerance of oral or IV corticosteroids, including IV methylprednisolone administered according to the country label, including:\n\n    * Psychosis not controlled by a treatment\n    * Hypersensitivity to any of the constituents or excipients of the preceding steroids\n18. Current or prior treatment with the following MS DMTs: fingolimod and other S1P receptor modulators, cladribine, natalizumab, anti-CD20 molecules, alemtuzumab, and chemotherapeutic agents\n19. Treatment with fumarates within 30 days prior to collection of Mo 0\u002FDay 0 mechanistic samples, Mo 0\u002FDay 0 MRI, and Mo 0\u002FDay 0 infusion\n20. (a) Current or prior treatment with any approved or experimental immunomodulatory therapies, unless reviewed and approved by the SAC (Section 3.6), or (b) Treatment with any experimental procedure for MS (e.g., treatment for chronic cerebrospinal venous insufficiency)\n21. Systemic corticosteroid therapy within 4 weeks prior to the collection of screening mechanistic samples and the screening MRI\n22. Systemic corticosteroid therapy within 4 weeks prior to the Mo 0\u002FDay 0 infusion\n23. Screening laboratory test results as follows:\n\n    * Positive infection screening tests for:\n\n      i. Hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) ii. Hepatitis C (HCV) antibody if positive screen for HCV RNA Polymerase Chain Reaction (PCR) iii. Rapid plasma reagin (RPR)\n    * A reactive RPR test unless followed by a subsequent negative RPR OR\n    * A reactive RPR test unless successful completion of treatment has been documented as well as a consultation with and clearance by infectious disease department iv. HIV v. At or within twelve months of screening:\n    * Positive QuantiFERON®-TB Gold test or positive purified protein derivative tuberculin skin test (PPD) (\\>5mm induration, regardless of Bacille Calmette-Guerin (BCG) vaccine administration) unless completion of treatment has been documented for active TB OR\n    * An indeterminate QuantiFERON®-TB Gold test unless followed by a subsequent negative PPD or negative QuantiFERON®-TB Gold test as well as a consultation with and clearance by infectious disease department\n    * Levels of serum immunoglobulin G (IgG) \\\u003C 3.3g\u002FL\n    * Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m2 using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n    * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.0 x the upper limit of normal (ULN)\n    * Platelet count \\\u003C 100,000 plt\u002FµL (\\\u003C100 x 10⁹\u002FL)\n    * Hemoglobin \\\u003C 10 g\u002FdL\n    * Absolute neutrophil count \\\u003C 1.5 x 10⁹\u002FL\n    * Absolute lymphocyte count \\\u003C 1.2 x 10⁹\u002FL\n24. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.","55 Years",{"count":540,"type":22},123,[379],"This study is a prospective, multi-center, randomized, double blinded, placebo-controlled study of OCR treatment-discontinuation in patients with early RMS. All eligible participants will be initiated on OCR using the standard approved administration schedule of two 300 mg infusions separated by 14 days (i.e., Days 0 and 14) for a total of 600 mg, followed by 600 mg infusions at Month 6,12, 18, and 24. At Month 24, participants will be randomized (2:1) to one of two Arms with randomized treatment beginning at Month 30: Arm 1: placebo infusions every 6 months; or Arm 2: OCR infusions every 6 months. The treatment period will be for a total of 48 months.",[28],[545,207,546],"Ocrelizumab","Relapse",{"date":413,"type":38},{"date":549,"type":38},"2023-01-12",{"date":551,"type":22},"2030-11-01",{"name":294,"class":295},13,{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":561,"minAge":562,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":277,"phases":4,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":46},"100549419","a-study-evaluating-the-effect-of-briumvi-ublituximab-on-pregnancy-and-infant-outcomes-in-participants-with-multiple-sclerosis-ms-100549419","NCT06433765","A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)","BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®","Inclusion Criteria:\n\n1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.\n2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.\n3. Diagnosis of MS.\n4. Currently or recently (within 1 year of pregnancy outcome) pregnant.\n5. Authorization from healthcare provider to provide data to registry.\n\nExclusion Criteria:\n\n1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.\n2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).\n3. Exposure to known teratogens and\u002For investigational medications during pregnancy.","FEMALE","15 Years","50 Years",{"count":565,"type":22},728,"The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.",[28],"2026-06-17",{"date":522,"type":38},{"date":571,"type":38},"2024-06-01",{"date":573,"type":22},"2035-03-31",{"name":575,"class":163},"TG Therapeutics, Inc.",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":277,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":595},"100549418","a-study-evaluating-the-real-world-experience-of-participants-treated-with-briumvi-ublituximab-xiiy-for-relapsing-multiple-sclerosis-rms-100549418","NCT06433752","A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)","REal World ExperieNce With BRIUMVI® (UblituximAB-xiiy) Treated Patients: A Longitudinal REgistry Study (ENABLE)","ENABLE","Inclusion Criteria:\n\n1. Confirmed Multiple Sclerosis (MS) diagnosis.\n2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included.\n\nExclusion Criteria:\n\n1. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration.\n2. Any active infection (e.g., active Hepatitis B virus \\[HBV\\])\n3. Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.",{"count":585,"type":22},2000,"The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting",[588,28],"Relapsing Multiple Sclerosis",{"date":522,"type":38},{"date":591,"type":38},"2024-07-22",{"date":593,"type":22},"2032-04-01",{"name":575,"class":163},90,{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":403,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":612,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":46},"100294160","phase-1-targeting-residual-activity-by-precision-biomarker-guided-combination-therapies-of-multiple-sclerosis-trap-ms-100294160","NCT03109288","Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)","* INCLUSION CRITERIA:\n* Enrolled in 09-I-0032 protocol.\n* Clinically definite MS.\n* Age \\>=18 years at time of study enrollment.\n* Expanded Disability Status Scale (EDSS) 1.0-7.5.\n* For progressive MS cohort enrollment:\n\n  * Documented sustained clinical progression of at least 0.5 CombiWISE points\u002Fyear on stable therapy (or untreated)\n\n    * If follow-up is \\\u003C3 years, CombiWISE progression slopes are measured by \\>= 4 time points regression analysis of CombiWISE values spanning at least 18 months (1.5 years)\n    * If follow-up is \\>=3 years, CombiWISE progression slopes are measured by \\>= 2 time-points regression analysis of CombiWISE values spanning at least 36 months (3 years)\n  * Because currently only NDS utilizes CombiWISE scale, the progression slopes will be determined via 09-I-0032 natural history protocol that contains completely overlapping procedures.\n  * It is possible that after other MS centers start using CombiWISE scale, this progression criterion may be derived from outside data, as long as they are adequately documented.\n* For non-progressing MS with residual disability cohort enrollment:\n\n  * CombiWISE slope on stable therapy (derived identically as in progressive MS cohort) \\>0 and \\\u003C0.5 CombiWISE units\u002Fyear (i.e., neurological deficit that is no longer improving)\n  * CombiWISE at the end of screening period \\>10 (i.e., sustained residual disability)\n* Women who can become pregnant must be willing to use a medically acceptable form of birth control, while being treated on this study.\n* Patients on current FDA-approved DMTs will be enrolled with the understanding that the underlying FDA-approved therapy must remain stable during this protocol. If patient desires and\u002For his\u002Fher medical condition requires changing FDA-approved DMT during the duration of this protocol, the drugs administered under this protocol will be withdrawn, to establish new baseline of CSF biomarkers under changed therapy, and, if necessary, to establish new progression rate. New baseline of CSF biomarkers on changed therapy can be established after 6 months of new therapy.\n\n  * Because the efficacy of current DMTs decreases with patient s age so that on average, zero percent efficacy on disability progression occurs after age 53, only those patients who change to higher potency therapy (i.e., treatment escalation) before age 53 will need to repeat the entire process of establishing baseline progression rate: go back to \\>= 1.5 year baseline period on new DMT to verify that the rate of progression remains \\>=0.5 CombiWISE points\u002Fyear.\n  * Following therapeutic change that occurs before age 53 will be considered treatment escalation: 1. Initiation of any FDA-approved DMT in previously untreated subject or 2. Change from any low potency (i.e., copaxone, teriflunomide, interferon beta preparations, dimethyl or monomethyl fumarate and fingolimod) to any high potency drugs (i.e., any B-cell depleting agents, natalizumab, alemtuzumab, siponimod, ozanimod and cladribine). All other therapy changes (i.e., parallel change from low efficacy to low efficacy or from high efficacy to high efficacy, as well as discontinuation of treatment after age 53) will require new CSF baseline (6 months after such therapy change), but will not require 18 months to calculate new CombiWISE slope.\n  * After new CSF baseline, and, if necessary, new CombiWISE progression slopes are established, patient can be matched to the same monotherapy or combination therapy regimen they were on before the immunomodulatory DMT change.\n* Willing and able to participate in all aspects of the protocol.\n* Able and willing to provide informed consent.\n\nEXCLUSION CRITERIA:\n\n* Clinically significant medical disorders that, in the judgment of the investigators, could expose the patient to undue risk of harm or prevent the patient from safely completing all required elements of the study (such as, but not limited to significant cerebrovascular disease, ischemic cardiomyopathy, clotting disorder, other neurodegenerative disorder, substance abuse or significant psychiatric disorder such as depression with suicidal ideations, unable to perform or tolerate MRI examinations).\n* Clinically significant medical disorders, other than MS that require chronic treatment with immunosuppressive or immunomodulatory agents.\n* Pregnancy or breastfeeding.\n* Abnormal screening\u002Fbaseline blood tests exceeding any of the limits defined below:\n\n  * Serum alanine transaminase or aspartate transaminase levels which are greater than three times the upper limit of normal values.\n  * Total white blood cell count \\\u003C 3 000\u002Fmm\\^3.\n  * Platelet count \\\u003C 85 000\u002Fmm\\^3.\n  * Serum creatinine level \\> 2.0 mg\u002FdL and eGFR (glomerular filtration rate) \\\u003C 60.\n  * Serological evidence of HIV, HTLV-1 or active hepatitis A, B or C.\n  * Positive pregnancy test.\n\nFollowing drug-specific exclusion criteria will be applied when assigning specific agent (these are not exclusions from the trial):\n\n* Pioglitazone\n\n  * Congestive heart failure.\n  * History of bladder carcinoma.\n  * Type 1 diabetes.\n  * Hypersensitivity to the drug.\n  * Taking teriflunomide (Aubagio) because of risk of hypoglycemia on this combination.\n* Dantrolene\n\n  * Hypersensitivity to the drug.\n  * Hepatic impairment\u002Factive hepatic disease (cannot be paired with pirfenidone due to risk of cumulative hepatoxicity).\n  * Persistent elevation of LFTs.\n  * History of previous drug\u002Fmedication or alcohol-related liver toxicities.\n* Pirfenidone\n\n  * Hypersensitivity to the drug.\n  * Hepatic impairment\u002Factive hepatic disease (cannot be paired with dantrolene due to risk of cumulative hepatoxicity).\n  * Persistent elevation of LFTs.\n  * Smoking.\n* Cilostazol\n\n  * Hypersensitivity to the drug.\n  * Congestive heart failure.\n  * Hemostatic disorder\u002Factive bleeding.\n  * Taking any S1P inhibitor (i.e., fingolimod, ozanimod, Siponimod or ponesimod) due to additive risk for QTc interval prolongation and thus increasing risk of arrythmia.\n* Leucovorin\n\n  * Hypersensitivity to the drug.\n  * Colorectal cancer (active).\n  * Vitamin B12 deficiency",{"count":603,"type":22},250,[151,128],"Background:\n\nIn people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined affect MS biomarkers. They want to see if a change in biomarker levels can predict which drugs a person with MS might respond to.\n\nObjective:\n\nTo see if signs of inflammation in CSF help predict a person s response to different drugs.\n\nEligibility:\n\nPeople ages 18 and older who:\n\n* Are in protocol 09-I-0032\n* Have progressive MS\n* Can stand and walk a few steps\n* Take an MS drug\n\nDesign:\n\nParticipants will be screened in protocol 09-I-0032.\n\nParticipants will take 1 of the 4 study drugs. Researchers will call after 1 month to see how they are doing. Some will start a second drug. They may take each drug or combination for up to 18 months.\n\nParticipants will have 2 visits a year for up to 6 years. Visits include:\n\n* Medical history\n* Physical exam\n* Blood and heart tests\n* X-rays and scans\n* Eye exam and tear collection\n* Lumbar puncture: A needle inserted between back bones removes some CSF.\n* Lymphocytapheresis: Blood is removed through a needle in one arm and run through a machine. The blood is returned through a needle in the other arm.\n* A sensor on the forehead records blood flow and oxygen use.\n* Participants may get a device for testing at home.\n\nParticipants will stop taking the drugs if they have taken 2 drugs together for 18 months or if they do not do well on the drugs.\n\nParticipants will be called 3 months later to see how they are doing.",[28],[608,28,609,610,611],"Targeted Therapy","Biomarkers","Combination Therapy","Progressive Multiple Sclerosis",{"date":522,"type":38},{"date":614,"type":38},"2017-08-11",{"date":616,"type":22},"2029-01-01",{"name":294,"class":295},{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":277,"phases":4,"briefSummary":627,"conditions":628,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":46},"100644402","development-of-pain-management-jitai-content-in-multiple-sclerosis-and-spinal-cord-injury-100644402","NCT07663266","Development of Pain Management JITAI Content in Multiple Sclerosis and Spinal Cord Injury","Development of Pain Management Just-In-Time Adaptive Interventions (JITAI) Content in Multiple Sclerosis and Spinal Cord Injury","Inclusion Criteria:\n\n* Able to read and converse fluently in English\n* Multiple sclerosis (MS) or Spinal Cord Injury (SCI) diagnosis\n* Chronic pain ( ≥ 4 on average using a 0-10 NRS for 3-month duration)\n* Access to an internet connected device with a camera and microphone for participating in virtual interview\u002Ffocus group.\n\nExclusion Criteria:\n\n* Cognitive or other impairment (e.g., hearing) that precludes study participation.",{"count":626,"type":22},14,"Just-In-Time Adaptive Interventions (JITAIs) offer a framework for delivering personalized behavioral support using time-varying data to optimize the timing and type of intervention content. This project will develop the foundational components of a JITAI tailored to adults with chronic pain and either MS or SCI by drawing on symptom self-management content from existing programs (PainGuide, MyMSToolkit, and MySCIToolkit). Intervention content and delivery parameters will be refined through stakeholder engagement via structured interviews to ensure relevance, acceptability, and feasibility.",[28,629],"Spinal Cord Injury","2026-06-16",{"date":413,"type":38},{"date":633,"type":38},"2026-05-25",{"date":635,"type":22},"2026-07",{"name":637,"class":45},"University of Michigan"]