[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-sclerosis-relapsing-remitting\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-sclerosis-relapsing-remitting":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,54,84,115,142,170,198,229,255,281,303,326,355,377,402,423,446,464,493,518,545,574],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100466892","phase-1-assessing-changes-in-multi-parametric-mri-in-ms-patients-taking-clemastine-fumarate-as-a-myelin-repair-therapy-100466892",false,"NCT05359653","Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy","A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy","ReVIVE","Inclusion Criteria:\n\n* Written informed consent must be obtained prior to any assessment being performed.\n* Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of \\\u003C 15 years\n* Male or female patients aged 18-55 years (inclusive)\n* Use of appropriate contraception during period of trial (women). Before entry women must be:\n\n  * Post-menopausal for at least 1 year OR\n  * Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, male partner vasectomy or otherwise incapable of pregnancy) OR\n  * Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study OR\n  * Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) OR\n  * Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject) Period abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) is not an acceptable method.\n\nExclusion Criteria:\n\n* Radiologic identification of marked brain atrophy relative to patients age based on recent MRI and interpretation of expert neuroradiologist or PI\n* New lesion in most recent MRI (within 3 months)\n* Hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.\n* Treatment with corticosteroids within 30 days prior to screening.\n* Expanded Disability Status Scale (EDSS) ≥ 4.5\n* History of significant cardiac conduction block.\n* History of cancer.\n* Suicidal ideation or behavior in 6 months prior to baseline.\n* Pregnancy, breastfeeding or planning to become pregnant.\n* Involved with other study protocols simultaneously without prior approval.\n* Concomitant use of any other putative remyelinating therapy as determined by the investigator.\n* Prior treatment with total lymphoid irradiation, T cell or T cell receptor vaccination.\n* Prior treatment with alemtuzumab, mitoxantrone, or cyclophosphamide.\n* Serum creatinine \\> 1.5 mg\u002FdL; aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase \\> 2 times the upper limit of normal. (Reported within 72 hours)\n* History of drug or alcohol abuse within the past year.\n* Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid \\[MMA\\] and homocysteine) or untreated hypothyroidism.\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that in the PI's judgment may affect the interpretation of study results or patient safety.\n* History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study\n* Inability to participate in MRI, including extreme claustrophobia.\n* Any dental braces or permanent or undetachable metals in the jaw or face.","ALL","18 Years","55 Years",{"count":21,"type":22},74,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments.\n\nNo reparative therapies exist for the treatment of multiple sclerosis. Clemastine fumarate was identified along with a series of other antimuscarinic medications as a potential remyelinating agent using the micropillar screen (BIMA) developed at the University of California, San Francisco (UCSF). Following in vivo validation, an FDA IND exemption was granted to investigate clemastine for the treatment of multiple sclerosis in the context of chronic optic neuropathy. That pilot study was recently completed and is the first randomized control trial documenting efficacy for a putative remyelinating agent for the treatment of MS. The preselected primary efficacy endpoint (visual evoked potential) was met and a strong trend to benefit was seen for the principal secondary endpoint assessing function (low contrast visual acuity). That trial number was 13-11577.\n\nThis study seeks to follow up on that study and examine clemastine fumarate's protective and reparative effects in the context of chronic demyelinating brain lesions as imaged by multi-parametric MRI assessments. The investigators will be assessing the effects of clemastine fumarate as a remyelinating therapy and assessing its effect on MRI metrics of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis.\n\nIn addition to using conventional multi-parametric MRI assessments, this study will also evaluate a new MRI technique called Ultrashort Echo Time (UTE) MRI to assess the effects of clemastine fumarate as a remyelinating therapy of chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.",[29,30,31,32,33,34,35],"Multiple Sclerosis (MS)","Multiple Sclerosis, Relapsing-Remitting","Multiple Sclerosis, Primary Progressive","Multiple Sclerosis, Chronic Progressive","Multiple Sclerosis Relapse","Multiple Sclerosis Brain Lesion","Multiple Sclerosis Benign",[37,38,39,40],"multiple sclerosis","mri","brain","spinal cord","RECRUITING","2026-06-30",{"date":44,"type":45},"2026-07-02","ACTUAL",{"date":47,"type":45},"2023-08-01",{"date":49,"type":22},"2027-06-01",{"name":51,"class":52},"University of California, San Francisco","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":53},"100586785","motor-learning-of-fall-resistant-skills-through-slip-and-trip-exposure-in-multiple-sclerosis-100586785","NCT06919900","Motor Learning of Fall Resistant Skills Through Slip and Trip Exposure in Multiple Sclerosis","STRES-MS","Inclusion Criteria:\n\n1. Clinically confirmed multiple sclerosis\n2. At least 45 years old\n3. Able to walk independently at least 25 feet\n4. Able to stand independently for at least 30 seconds\n5. Patient Determined Disability Steps score between 0 and 4\n6. Free from pregnancy\n7. Montreal Cognitive Assessment score of 23 or higher\n\nExclusion Criteria:\n\n1. Previous experience with perturbation training\n2. T-score from the dual x-ray absorptiometry (DXA) scan of less than -2.5\n3. Coexisting psychiatric disorders or other neurological conditions, severe medical illness, or cardiovascular diseases\n4. Participants have had a relapse in the past 8 weeks","45 Years","89 Years",{"count":64,"type":22},64,[66],"NA","The primary purpose of this interventional study is to examine the overall motor learning capacity from exposure to repeated perturbations among ambulatory people with multiple sclerosis (MS). This project will advance our understanding of learning new motor skills from exposure to external perturbations. If it is proven that people with MS can learn motor skills from perturbation training, the findings from this study will pave a theoretical foundation for applying perturbation training as a promising fall prevention intervention for people with MS.",[69],"Multiple Sclerosis (Relapsing Remitting)",[71,72,73,74],"Falls","Fall prevention","Slips","Trips","2026-06-15",{"date":77,"type":45},"2026-06-17",{"date":79,"type":45},"2026-04-06",{"date":81,"type":22},"2028-12",{"name":83,"class":52},"Georgia State University",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100547460","phase-3-study-to-evaluate-the-effectiveness-and-safety-of-ozanimod-compared-to-fingolimod-in-children-and-adolescents-with-relapsing-remitting-multiple-sclerosis-100547460","NCT06408259","Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis","A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis","Inclusion Criteria:\n\n* Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.\n* Meets at least 1 of the following criteria for disease activity:\n\n  i) At least 1 MS relapse\u002Fattack in the previous year prior to screening.\n\nii) At least 2 MS relapses\u002Fattacks in the previous 2 years prior to screening.\n\niii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).\n\n\\- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.\n\nExclusion Criteria:\n\n* Diagnosis of progressive forms of MS.\n* Active or chronic disease of the immune system other than MS.\n* Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","10 Years","17 Years",{"count":94,"type":22},194,[96],"PHASE3","The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).",[30],[100,101,102,103],"Multiple Sclerosis","Relapsing-Remitting","Ozanimod","Zeposia®","2026-04-23",{"date":106,"type":45},"2026-04-28",{"date":108,"type":45},"2025-04-08",{"date":110,"type":22},"2036-07-13",{"name":112,"class":113},"Bristol-Myers Squibb","INDUSTRY",33,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":53},"100537346","intermittent-hypoxia-in-persons-with-multiple-sclerosis-100537346","NCT06276634","Intermittent Hypoxia in Persons With Multiple Sclerosis","Intermittent Hypoxia Initiated Motor Plasticity in Individuals With Multiple Sclerosis","Inclusion Criteria:\n\n* Diagnoses of relapsing form of MS (including relapsing-remitting MS and secondary-progressive MS)\n* Expanded Disability Status Scale (EDSS) score of at least 3 and no more than 6.5\n* Motor Functional System Scale (FSS) between 2-4\n* Relapse free for at least 1 year\n* Age ≥ 18 years and ≤ 75 years\n* Safe to be scanned based on MRI questionnaire\n* Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening\n\nExclusion Criteria:\n\n* Active contrast-enhancing MS lesions, or diffusion positive lesions suggestive of acute cerebrovascular disease on baseline MRI scan\n* Uncontrolled hypertension (Systolic between 85 and 140, diastolic between 90 and 55)\n* History of epilepsy\n* Chronic obstructive pulmonary disease\n* Uncontrolled Sleep apnea\n* Pregnancy","75 Years",{"count":124,"type":22},21,[66],"This study aims to understand the mechanisms of a novel intervention involving breathing short durations of low levels of oxygen for persons with multiple sclerosis (MS). This intervention with low levels of oxygen is called Acute Intermittent Hypoxia (AIH), the levels of oxygen experienced are similar to breathing the air on a tall mountain, for less than 1 minute at a time. Previous studies have shown that AIH is a safe and effective way to increase strength in persons with MS. Here the investigators aim to look at brain activation and ankle strength before and after AIH to gain a better understanding of how the AIH may improve strength in those persons with MS.",[100,128,129],"Multiple Sclerosis-Relapsing-Remitting","Multiple Sclerosis, Secondary Progressive",[37,131,132],"AIH","Hypoxia","2026-03-18",{"date":135,"type":45},"2026-03-20",{"date":137,"type":45},"2024-04-30",{"date":139,"type":22},"2027-01",{"name":141,"class":52},"Shirley Ryan AbilityLab",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":122,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":53},"100546130","effects-of-acute-intermittent-hypoxia-on-neuroplasticity-in-ms-100546130","NCT06390930","Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS","Investigating the Effects of Acute Intermittent Hypoxia on Neuroplasticity in Persons With Multiple Sclerosis","Inclusion Criteria:\n\n* Diagnosis of relapsing-remitting MS according to the McDonald criteria, over 5 years ago\n* Relapse free for at least 6 months\n* Expanded Disability Status Scale (EDSS) ≤7\n* Index finger abduction strength \\\u003C5 according to Medical Research Council Scale, or 9-Hole Peg Test score \\>20 seconds in at least one hand\n* Stable disease modifying therapies for at least 6 months\n* Individuals taking dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening\n\nExclusion Criteria:\n\n* Another diagnosis (e.g., peripheral neuropathies or orthopedic) affecting upper limb function\n* Mini-Mental State Examination (MMSE) score \\\u003C24\n* Modified Ashworth Scale score \\>3 on elbow joint\n* Uncontrolled hypertension or hypotension (outside 140\u002F90 and 85\u002F55 mmHg)\n* History of epilepsy, chronic obstructive pulmonary disease, or sleep apnea\n* Unstable medical conditions, ongoing upper limb therapy, or musculoskeletal pain\n* Pregnancy as confirmed by urine test",{"count":5,"type":22},[66],"This study seeks to explore changes in the neural pathways and arm function following a breathing intervention in the multiple sclerosis (MS) population. The breathing intervention, known as Acute Intermittent Hypoxia (AIH), involves breathing brief bouts of low levels of oxygen. Research has found AIH to be a safe and effective intervention resulting in increased ankle strength in people with MS. Here, the study examines arm and hand function before and after AIH. In order to better understand the brain and spinal cord response to AIH, the investigators will measure muscle response, and signals sent from the brain to the arm muscles before and after AIH.",[100,30,129],[37,154,155,156,157,158,159,160,161],"plasticity","neuroplasticity","motoneuron","aih","hypoxia","Acute Intermittent Hypoxia","arm","upper extremity","2026-02-19",{"date":164,"type":45},"2026-02-23",{"date":166,"type":45},"2025-02-01",{"date":168,"type":22},"2027-07",{"name":141,"class":52},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":53},"100559854","fatigue-alleviation-through-neuromodulating-therapy-in-multiple-sclerosis-100559854","NCT06569550","Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis","Neuromodulation of the Left Premotor Cortex With Transcranial Magnetic Stimulation to Alleviate Fatigue in Multiple Sclerosis - a Randomised Controlled Clinical Trial","FANTiMS","Inclusion Criteria:\n\n* A confirmed diagnosis of relapse-remitting or secondary progressive multiple sclerosis, according to most recent McDonald's criteria (Thompson et al., 2018). This diagnosis must not be more recent than 3 months\n* Must have fatigue as a complaint, and an FSMC score corresponding to at least moderate fatigue (\\>53)\n* Stable MS medication for at least 3 months\n\nExclusion Criteria:\n\n* Pregnancy, any subject with the potential to become pregnant must ensure against this (e.g. by taking oral contraceptives, or other high efficacy method)\n* MS Relapse or steroid treatment within 3 months prior to inclusion\n* Current treatment targeted towards fatigue, or previous if discontinued within 3 months prior to inclusion\n* History of neurologic disease or other significant medical conditions, aside from MS\n* EDSS \\> 6.5\n* Major psychiatric disorder, including current clinical depression.\n* Intake of medication that primarily acts on CNS or neurotransmission, except SSRI or SNRI\n* Pacemaker or other implanted electronic devices\n* Any intracranial metal\n* Any metallic implant incompatible with MR scanning\n* Claustrophobia\n* Either patient or their close relatives suffering from epilepsy\n* Current Drug or alcohol abuse","65 Years",{"count":180,"type":22},60,[66],"The goal of this clinical trial is to learn if repetitive Transcranial Magnetic Stimulation (rTMS) of the left premotor cortex can lessen fatigue in patients with Multiple Sclerosis, and if this is a feasible intervention. It will also give further information on fatigue in Multiple Sclerosis. The main questions it aims to answer is:\n\n* Does premotor rTMS decrease fatigue symptoms in patients with Multiple Sclerosis?\n* Is the change in fatigue reflected in an altered balance between brain excitation and inhibition in the targeted premotor cortex?\n\nResearchers will compare real rTMS with sham rTMS (which does not stimulate with a magnetic field), to see if real rTMS works to alleviate fatigue.\n\nParticipants will:\n\n* Receive real or sham rTMS for 30 minutes, 5 days in a row\n* Visit the clinic before and 6 days after for baseline and follow-up\n* Fill out on-line questionnaires 1 day and 4 weeks after the end of intervention\n* Undergo a total of 3 brain scans (Magnetic Resonance Imaging at ultra-high field), at baseline, end of intervention, and follow-up\n* Undergo lab neurophysiological measurements before and after the first intervention session\n* Keep a fatigue diary and wear an activity tracker in the period before and after the intervention",[30,184],"Fatigue",[186,187,188],"Transcranial Magnetic Stimulation, Repetitive","Magnetic Resonance Imaging","Magnetic Resonance Imaging, Spectroscopy","2026-01-27",{"date":191,"type":45},"2026-01-28",{"date":193,"type":45},"2024-08-14",{"date":195,"type":22},"2026-11-01",{"name":197,"class":52},"Danish Research Centre for Magnetic Resonance",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":208,"conditions":209,"keywords":212,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":53},"100614536","clinnova-ms-a-prospective-cohort-study-of-patients-with-multiple-sclerosis-a-trans-regional-digital-health-effort-unlocking-the-potential-of-artificial-intelligence-and-data-science-in-health-care-100614536","NCT07280871","Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care","Clinnova-MS","Inclusion Criteria:\n\n1. Signed informed consent form\n2. ≥ 18 years of age\n3. Willing and able to comply with the protocol for the duration of the study including data and samples collection as well as study visits and examinations.\n4. Diagnosed with MS according to the revised McDonald criteria 2017 or revised McDonald criteria 2024, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS) AND early disease stages (\\\u003C 3 years), OR presenting at hospital for evaluation of a change in therapy (flare) OR transitioning phase to progressive disease as evaluated based on EDSS.\n\nExclusion Criteria:\n\n1. Diagnosis uncertain (no fulfilment of inclusion criteria)\n2. Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits such as mental disability that makes it difficult or impossible to answer questionnaires.\n3. Not fluent in any of the following languages: French, English or German.\n4. Known pregnancy before the inclusion into the study",{"count":206,"type":22},100,"OBSERVATIONAL","The Clinnova-Multiple Sclerosis (MS) study is part of the Clinnova program (NCT06526364; NCT06235684 and NCT05733702), which seeks to advance precision medicine and the digitalization of healthcare through high-quality, interoperable health data.\n\nThis program focuses on people with multiple sclerosis (MS) and aims to identify objective surrogate markers derived from clinical, epidemiological, imaging, and omics data that can predict disease activity, such as progression or relapses.\n\nBy combining data science and artificial intelligence, the project seeks to improve patient stratification, support personalized therapeutic decisions, and provide insights into the mechanisms underlying treatment response and disease progression.\n\nAlthough many therapies are available for MS, it remains challenging to determine the most appropriate strategy for each patient and to prevent long-term disability. Current treatments mainly target relapses and inflammation, with limited effects on chronic progression. Clinnova-MS will collect and analyze real-world and research data to better understand variability in disease activity and treatment outcomes, enabling more precise, evidence-based care within the standard of care. This study represents the first step toward the broader Clinnova objective: developing sustainable, personalized, and preventive healthcare for people living with MS.",[30,32,210,211],"Clinically Isolated Syndrome","Primary Progressive Multiple Sclerosis",[213,214,215,216,217],"AI","Machine Learning","MS","phenotyping","personalised medicine","NOT_YET_RECRUITING","2025-12-31",{"date":221,"type":45},"2026-01-06",{"date":223,"type":22},"2026-06",{"date":225,"type":22},"2040-06",{"name":227,"class":228},"Luxembourg Institute of Health","OTHER_GOV",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":53},"100556535","clinnova-ms-a-prospective-cohort-study-of-patients-with-multiple-sclerosis-switzerland-100556535","NCT06526364","Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland)","Clinnova-MS: a Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care (Switzerland)","Inclusion Criteria:\n\n* Age ≥18\n* Participants are willing and able to comply with the protocol, including undergoing data and samples collection as well as study visits and examinations.\n* Signed informed consent form\n* In possession of a Healios+Me app compatible smartphone (iOS\u002FAndroid)\n* Corrected close visual acuity of ≥0.5\n* Hand motor skills sufficient for using a smartphone\n* Ability to follow the study procedures\n* Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (clinically isolated syndrome, RRMS, SPMS, PPMS) AND early disease stages (\\\u003C 3 years) OR transitioning phase to progressive disease as evaluated based on Expanded Disability Status Scale (EDSS).\n* Enrolled in the SMSC at University Hospital Basel\n\nThere are no specific exclusion criteria.",{"count":206,"type":22},"This prospective cohort study is part of the Clinnova programme and aims to (i) identify clinical imaging and omics characteristics associated with early Multiple Sclerosis (MS) and with transitioning phases to progressive MS, as well as (ii) to investigate digital biomarkers allowing the continuous clinical monitoring of those patients.",[100,30,31,129],[240,241,242,243,244,245],"Immune-meditated Diseases","Artificial Intelligence","Personalized medicine","Treatment change","Phenotyping","Clinnova","2025-12-18",{"date":248,"type":45},"2025-12-26",{"date":250,"type":45},"2024-12-10",{"date":252,"type":22},"2029-06",{"name":254,"class":52},"University Hospital, Basel, Switzerland",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":262,"minAge":18,"maxAge":61,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":53},"100421513","behavioral-intervention-for-physical-activity-and-sexual-dysfunction-in-multiple-sclerosis-100421513","NCT04768777","Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis","BIPAMS-SD","Inclusion Criteria:\n\n1. Female\n2. Diagnosed of relapsing remmiting multiple sclerosis\n3. Relapse free in the past 30 days\n4. Initial confirmation of sexual dysfunction (based on a semi-structured interview on sexual dysfunction diagnostic criteria in DSM-5)\n5. Currently in a committed relationship with a partner who does not have a sexual disorder or sexual dysfunction\n6. Internet and email access\n7. Willingness to complete the questionnaires, wear the pedometer, and undergo randomization\n8. Insufficient physical activity \\[not meeting current physical activity guidelines based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire (GLTEQ)\\]\n9. Ability to ambulate without assistance \\[self-report and Patient-Determined Disease Steps (PDDS) score between 0 and 2 (mild ambulatory disability)\\]\n10. Age between 18 and 45 years\n11. English as primary language\n\n    \\-\n\n    Exclusion Criteria:\n\n1\\. Moderate or high risk for contraindications of possible injury or death when undertaking strenous or maximal exercise\n\n\\-","FEMALE",{"count":264,"type":22},30,[66],"The prevalence of sexual dysfunction is higher among women with multiple sclerosis (MS) than women in the general population. The presence of sexual dysfunction is associated with decreased well-being and quality of life. There is limited research supporting pharmacological and other therapeutic approaches for managing sexual dysfunction in MS. Physical activity has beneficial effects on many of the consequences of MS, and physical activity represents a promising non-pharmacological approach for managing symptoms of sexual dysfunction in MS. The proposed research examines the effect of an Internet-delivered lifestyle physical activity intervention for improving sexual dysfunction in women with MS. The research proposed, if successful, will provide evidence for the efficacy of physical activity as a translatable approach for managing sexual dysfunction among women with MS.",[30,268],"Sexual Dysfunction",[270,271],"physical activity","sexual behaviour","2025-12-16",{"date":274,"type":45},"2025-12-22",{"date":276,"type":22},"2026-12-01",{"date":278,"type":22},"2026-12-30",{"name":280,"class":52},"University of Alabama at Birmingham",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":17,"minAge":288,"maxAge":122,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":53},"100513389","impact-of-the-cionic-neural-sleeve-on-mobility-in-multiple-sclerosis-100513389","NCT05964829","Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis","A Crossover Study Evaluating the Impact of the Cionic Neural Sleeve on Mobility, Disability, Fall Risk, and Physical Activity in Multiple Sclerosis","Inclusion Criteria:\n\n* Persons with relapsing-remitting or progressive forms of MS between the ages of 22 and 75\n* Ability to ambulate at least 15 minutes throughout the day for five days per week, with or without assistive device\n* Adequate cognitive and communicative function as assessed via Telephone Interview for Cognitive Status (TICS) to identify persons with dementia\n* Able to tolerate the Neural Sleeve device for up to 8 hours per day\n* T25FWT time between 8 and 45 seconds\n* No recent change in medication or recent exacerbation of symptoms over the last 60 days\n* Patient-determined Disease Steps score between 3 and 5 or EDSS score between 4 and 6.5\n\nExclusion Criteria:\n\n* Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation\n* Absent sensation in the impacted or more impacted leg\n* Inadequate response to stimulation, defined by inability to achieve muscle contraction or unable to tolerate stimulation\n* Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)\u002Fknee ankle foot orthosis (KAFO) if utilized\n* History of falls greater than once a week\n* No use of FES devices in the past year\n* Demand-type cardiac pacemaker or defibrillator\n* Malignant tumor in the impacted or more impacted leg\n* Existing thrombosis in the impacted or more impacted leg\n* Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation","22 Years",{"count":290,"type":22},14,[66],"The purpose of this research is to support the clinical value of the Cionic Neural Sleeve for individuals diagnosed with multiple sclerosis (MS).",[100,30,32],"2025-09-19",{"date":296,"type":45},"2025-09-24",{"date":298,"type":45},"2023-09-04",{"date":300,"type":22},"2026-07",{"name":302,"class":113},"Cionic, Inc.",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":178,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":314,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":53},"100512894","treatment-of-cognitive-deficits-in-multiple-sclerosis-with-high-definition-transcranial-direct-current-stimulation-100512894","NCT05958381","Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation","MS-HDtDCS","Inclusion Criteria:\n\nº Diagnosed with relapsing-remitting multiple sclerosis (RRMS)\n\nº Memory retrieval deficit based on neuropsychological testing done in our lab\n\nº Must be fluent in speaking and reading English.\n\nExclusion Criteria:\n\nº Relapse or acute MS exacerbation or a course of steroids in the two months preceding the testing\n\nº Participants using benzodiazepines must have been on a stable dose for at least two months\n\nº Potentially confounding psychological or neurological disorder, including:\n\n* dementia of any type\n* epilepsy or other seizure disorders\n* severe traumatic brain injury\n* brain tumor\n* present drug abuse\n* stroke\n* blood vessel abnormalities in the brain\n* Parkinson's disease\n* Huntington's disease\n\nº inability to give informed consent\n\nº cranial implants\n\nº skull defects that affect tDCS administration\n\nº use of medications that interact with or potentially interact with tDCS effects, including:\n\n* anti-convulsants\n* L-dopa\n* carbamazepine\n* sulpiride\n* pergolide\n* lorazepam\n* rivastigmine\n* dextromethorphan\n* D-cycloserine\n* flunarizine\n* ropinirole\n* stimulants (dextroamphetamine\u002Famphetamine\u002Fmodafinil\u002Farmodafinil) must be stopped during enrollment",{"count":206,"type":22},[66],"The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.",[30],[315,37,316],"transcranial direct current stimulation (tDCS)","electroencephalography (EEG)","2025-08-11",{"date":319,"type":45},"2025-08-14",{"date":321,"type":45},"2023-10-18",{"date":323,"type":22},"2027-06-30",{"name":325,"class":52},"The University of Texas at Dallas",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":333,"minAge":18,"maxAge":19,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":354},"100355650","phase-2-totem-rrms--testosterone-treatment-on-neuroprotection-and-myelin-repair-in-relapsing-remitting-multiple-sclerosis-100355650","NCT03910738","TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis","TOTEM-RRMS","Inclusion Criteria:\n\n* Man between 18 and 55 years\n* Patient affiliated to a social health insurance plan\n* Patient able to understand the objectives and risks related to the research and able to comply with the requirements of the protocol throughout the duration of the study\n* Patient having been informed of the results of the prior medical examination\n* Patient having signed an informed consent\n* Confirmed and documented diagnosis of MS, as defined by the revised McDonald criteria,\n* Patient who have been receiving one of the following disease modifying therapies for at least one year prior to randomization: natalizumab , fingolimod, ponesimod, ocrelizumab, or ofatumumab, in accordance with their prescribing information. Switching from one molecule to another during the previous year is also permitted, provided that the switch was motivated by a non-neurological reason (relapse, MRI activity). Patients receiving ocrelizumab within 6 to 9 months are eligible, provided they have received full-dose ocrelizumab for at least 2 years.\n* Biological hypogonadism defined by serum total testosterone levels below 20 nmol \u002F L (checked by blood sampling during the screening visit)\n* For patients under natalizumab : Negative status for JC virus or JC virus synthesis index ≤ 1.5 (checked by blood sampling at the inclusion visit)\n* No relapses in the year prior to inclusion\n* Disability status during the selection visit with an EDSS score of 0 to 7 (verified by questionnaire during the inclusion visit)\n* Stable neurological state in the month preceding randomization\n\nExclusion Criteria:\n\n* Patients with progressive MS (primary or secondary)\n* Patients with hypogonadism with clinical symptoms and treated with androgens\n* Patients with PSA (prostate specific antigen)\\> 2.5 ng \u002F ml (for an age less than 49 years old) or \\> 3.5 ng \u002F ml (for age ≥ 50 years) (checked by a blood test at the inclusion visit)\n* Patients with a hematocrit level \\> 54% (checked by blood sampling during the inclusion visit)\n* Patients refusing or unable to undergo an MRI\n* Patients with any other disease other than MS that may contribute to neurological symptoms and signs or affect their evaluation\n* Patients with neurological signs compatible with progressive multifocal leukoencephalopathy (PML) or confirmed leukoencephalopathy\n* Patients diagnosed with untreated sleep apnea\n* Patients with or having had cancer or tumors of the liver, heart, kidney, prostate or mammary gland\n* Patients with cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, uncontrolled diseases\n* Patients wishing to procreate during the study period\n* Patients with chronic infectious disease\n* Patients with organic or psychiatric disease compromise their ability to understand the information given and to follow the protocol\n* Patients with a history of hypersensitivity to treatment or any of the excipients, or drugs of similar chemical classes\n* Patients who used experimental drugs and \u002F or who participated in clinical drug trials in the 6 months prior to selection\n* Patient in exclusion period (determined by previous study or in progress)\n* Impossibility of giving information to the patient (subject in emergency situation, difficulties in understanding the subject or other)\n* Incapacitated subject (subject to a legal protection measure: safeguard of justice, curatorship, guardianship, future protection mandate, family habilitation)","MALE",{"count":335,"type":22},40,[26],"Centra nervous system (CNF) damage in multiple sclerosis (MS), are mainly attributed to myelin destruction, axonal abnormalities and subsequent degeneration, and are responsible for serious deficiencies. Current therapies are focused on the treatment of inflammation with several types of anti-inflammatory agents. However, there is an urgent need for innovative therapies promoting neuroregeneration and particularly myelin repair.\n\nIt has been demonstrated that testosterone can act through neural androgen receptors to promote proliferation and differentiation of oligodendrocyte precursors into mature oligodendrocytes in a cuprizone-induced animal model of demyelination. The rare clinical trials on testosterone are mainly exploratory. Here, we sought to demonstrate an effect of testosterone supplementation in testosterone-deficient patients in a multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial.\n\nThe main objective will be to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyzes.\n\nAs secondary objectives, we would like to study the impact of testosterone supplementation on other conventional and unconventional MRI parameters and on clinical outcomes (cognition, fatigue, quality of life, impact on work \u002F activity and anxiety \u002F depression).",[30],[340,341,342,343,344],"Neuroprotection","Remyelination","Relapsing Remitting Multiple sclerosis","Testosterone undecanoate","Diffusion tensor Imaging","2025-06-27",{"date":347,"type":45},"2025-06-29",{"date":349,"type":45},"2019-10-29",{"date":351,"type":22},"2027-12",{"name":353,"class":52},"University Hospital, Strasbourg, France",5,{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":361,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":53},"100316614","retinal-neuro-vascular-coupling-in-patients-with-multiple-sclerosis-100316614","NCT03401879","Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis","Inclusion criteria for healthy subjects:\n\n* Men and women aged over 18 years\n* Non-smokers\n* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant\n* Normal ophthalmic findings, ametropy \\\u003C 6 Dpt.\n\nInclusion criteria for patients with MS:\n\n* Men and women aged over 18 years\n* Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to clinical evaluation and McDonald criteria (revision 2010)\n* History of AON in one eye at least one year ago\n* Non-smokers\n* Normal ophthalmic findings, ametropy \\\u003C 6 Dpt.\n* Adequate visual acuity to allow participation in the ocular blood flow measurements\n* A potential participant has to be on stable doses of all medications he\u002Fshe is taking because of consisting illnesses according to medical history (except MS therapy itself which will be recorded separately) for at least 30 days prior inclusion, if considered relevant by the investigator.\n\nAny of the following will exclude a healthy subject from the study:\n\n* Diagnosis of \"possible MS\" according to the McDonald criteria (revision 2010)\n* Presence or history of a severe medical condition as judged by the clinical investigator\n* Untreated Arterial hypertension\n* History or family history of epilepsy\n* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator\n* Family history of MS, optic neuritis, neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders\n* History of inflammatory or infectious disease of central nervous system\n* Best corrected visual acuity \\\u003C 0.5 Snellen\n* Ametropy ≥ 6Dpt\n* Pregnancy or planned pregnancy\n* Alcoholism or substance abuse\n\nAny of the following will exclude a patient from the study:\n\n* Presence or history of a severe medical condition other than MS as judged by the clinical investigator\n* History of neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders\n* History of inflammatory or infectious disease of central nervous system other than MS\n* Untreated Arterial hypertension\n* History or family history of epilepsy\n* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator\n* Best corrected visual acuity \\\u003C 0.5 Snellen\n* Ametropy ≥ 6 Dpt\n* Pregnancy, planned pregnancy\n* Significant neurological disease other than MS, if considered relevant by the investigator\n* Alcoholism or substance abuse",true,{"count":363,"type":22},50,[66],"Multiple sclerosis (MS) affects approximately 2.3 million patients worldwide, with a global median prevalence of 33 per 100,000. MS is diagnosed at an average of 30 years and affects twice as many women as men. MS is traditionally diagnosed by the presentation of lesions of the central nervous system, disseminated in time and in space, proven by clinical examination and magnetic resonance imaging. Several anatomical parameters in the eye, both vascular and neural, have been found to be altered in MS patients.\n\nBecause of its unique optical properties, the eye offers the possibility of the non-invasive assessment of both structural and functional alterations in neuronal tissue. As the neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative changes in the brain are accompanied by structural and possibly also functional changes in the neuro-retina and the ocular vasculature.\n\nThe current study seeks to test the hypothesis that beside the known anatomical changes, also functional changes can be detected in the retina of patients with MS. For this purpose, flicker light induced hyperemia will be measured in the retina as a functional test to assess the coupling between neural activity and blood flow. Further, structural parameters such as retinal nerve fiber layer thickness and function parameters such as ocular blood flow and retinal oxygenation will be assessed and compared to age and sex matched controls.",[30,367],"Optic Neuritis","2025-05-20",{"date":370,"type":45},"2025-05-23",{"date":372,"type":45},"2018-02-01",{"date":374,"type":22},"2026-03",{"name":376,"class":52},"Medical University of Vienna",{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":53},"100571068","multiple-sclerosis-and-the-effects-of-ketogenic-diet-therapy-100571068","NCT06715436","Multiple Sclerosis and the Effects of Ketogenic Diet Therapy","The Effects of Ketogenic Diet Therapy Versus the Mediterranean Diet on Quality of Life in a Group of Patients With Multiple Sclerosis - the KETOMED-MS Study","Inclusion Criteria:\n\n* Diagnosis of relapsing-remitting MS (RRMS) or progressive MS (PMS)\n* Age between 18 and 60 years\n* BMI between 18.5 kg\u002Fm2 and 39.9 kg\u002Fm2\n* If on disease-modifying drugs, stable for 6 months, or no use of drugs in the previous 6 months\n* Ability to give verbal and written consent\n\nExclusion Criteria:\n\n* Patients actively engaged in a weight loss program or other specific diet (e.g. vegetarian, vegan); patients not willing to follow the assigned dietary pattern or patients with high adherence to MedDiet (MediLite score \\> 14)\n* Pregnancy or breastfeeding\n* Relapse or cortisone treatment within 30 days before study entry\n* Clinically relevant metabolic, progressive or malignant diseases\n* Intake of \\> 1 g\u002Fday of omega-3 fatty acid supplements\n* Underweight (BMI\\\u003C18.5 kg\u002Fm2) or severe obesity\n* Significant cognitive-cooperative impairment\n* Insulin-dependent diabetes mellitus (type I)\n* Weight loss greater than 5 kg within 2 months prior to study entry\n* Diagnosis or suspicion of an eating disorder\n* Kidney stones\n* Oral anticoagulant therapy\n* Known alcohol and drug abuse\n\nTelephonic interviews will be performed monthly to evaluate adherence to the dietary treatment and\u002For whether any changes in supplements use, physical activity, nutrition habits.","60 Years",{"count":386,"type":22},111,[66],"Multiple sclerosis (MS) is an inflammatory and immune-mediated neurological disease with multifactorial etiology. The specific etiopathogenetic mechanisms of MS are still unknown but it is clear that it results from a combination of genetic and environmental factors. Several studies have reported the possible role of diet as a risk factor for MS and its progression. To date, many dietary patterns and their association with MS have been studied, but data is still limited and inconclusive. Mediterranean Diet (MedDiet) has been associated with a lower risk of developing MS, compared to a Western-style diet. In one of investigators' studies, higher MedDiet adherence was associated with a 6-fold greater likelihood of having lower disease severity than those with low adherence. A significant restriction of carbohydrates (up to ketogenesis) can have beneficial effects on various parameters (inflammatory markers, oxidative stress, altered glucose metabolism) which are altered in subjects with MS. Ketogenic diet therapies (KDTs) have been recommended mainly for children with drug-resistant epilepsy, but in recent years they have been applied to Multiple Sclerosis. Preclinical studies in animal models evaluating the efficacy of KDTs in experimental autoimmune encephalomyelitis (EAE) found a beneficial effect of diet in slowing of disease progression, improvement of motor disability, reduction of inflammatory cytokines and reactive oxygen species. In a randomized study, improvements in health-related quality of life (HRQL) scores and a slight decrease in EDSS scores were found. An open-label, single-arm study of 20 patients with RRMS also reported that, after 6 months of MAD, no subjects had new or enlarging FLAIR\u002FT2 lesions, with a significant improvement in the EDSS score, the Modified Fatigue Impact Scale subscales and arm. A 3-arm parallel-arm randomized controlled pilot study was planned to determine the effectiveness of a modified Atkins diet (MAD) compared to a Mediterranean diet (MedDiet) on quality of life in a population with MS.",[30],[100,391,392],"Ketogenic Dietary Therapy","Mediterranean diet","2024-12-18",{"date":395,"type":45},"2024-12-20",{"date":397,"type":45},"2024-03-15",{"date":399,"type":22},"2025-09-15",{"name":401,"class":52},"IRCCS National Neurological Institute \"C. Mondino\" Foundation",{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":361,"sex":17,"minAge":18,"maxAge":384,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":53},"100546056","light-stimulation-to-improve-visual-function-after-optic-neuritis-in-persons-with-multiple-sclerosis-100546056","NCT06389968","Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis","Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung","ONSTIM","Inclusion Criteria:\n\n* Relapsing remitting multiple sclerosis or clinically isolated syndrome or no indication of chronic inflammatory central nervous system disease\n* Age 18-60 years\n* Optic neuritis within 1-3 months\n\nExclusion Criteria:\n\n* Epilepsy\n* Light-triggered migraine\n* Insufficient vision correction\n* Retinal disease (glaucoma, macular edema, macula degeneration, ...)",{"count":363,"type":22},[66],"The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis following optic neuritis (neuritis nervi optici) by means of a light stimulation.\n\nIn the treatment arm, two 80-second light stimulations are to be administered daily for 12 days in 25 persons with multiple sclerosis following recent optic neuritis (1-3 months). For the standardized application of light stimulation in the sense of standardized training, the light stimulation is to be carried out by watching a generated flicker video on a mobile phone. In a sham-intervened control group (sample size 25), the spontaneous course after optic neuritis will be recorded in parallel. Intensive neuronal stimulation of the visual pathway will be used to stimulate regenerative processes, which will be recorded by means of changes in high-contrast visual acuity (primary endpoint). Secondary endpoints are changes in a colored-contrast test, in 2.5% low contrast visual acuity, the peak conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography and optical coherence tomorgraphic angiography. These physiological parameters should help to understand the underlying processes of a potentially altered visual performance.",[30,367],"2024-11-20",{"date":416,"type":45},"2024-11-22",{"date":418,"type":45},"2024-08-01",{"date":420,"type":22},"2026-12-31",{"name":422,"class":52},"Technical University of Munich",{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":178,"enrollmentInfo":431,"targetDuration":433,"studyType":207,"phases":4,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":445},"100559673","multiple-sclerosis-treatment-with-autologous-hematopoietic-stem-cell-transplantation-in-the-netherlands-100559673","NCT06567197","Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation in the Netherlands","Multiple Sclerosis Treatment With Autologous Hematopoietic Stem Cell Transplantation (MS-ACT): A Long-term Prospective Observational Study in the Netherlands","MS-ACT","Inclusion Criteria:\n\n* All patients approved for treatment with aHSCT in the Netherlands in accordance with the Dutch criteria for aHSCT treatment for RRMS\n\nExclusion Criteria:\n\n* Contra-indications for treatment with aHSCT such as known hypersensitivity to the medication used for aHSCT\n* Clinically relevant comorbidities preventing safe use of medication used for aHSCT\n* Severe clinical depression\n* Active addiction to drugs or alcohol\n* Active infections such as but not limited to tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes simplex, varicella zoster, viral hepatitis, toxoplasmosis, HIV or syphilis.\n* Active malignancy or history of malignancy with the exception of local basal cell carcinoma or carcinoma in situ of the cervix",{"count":432,"type":22},24,"5 Years","The goal of this observational study is to study the long-term effects of autologous hematopoietic stem cell transplantation (aHSCT) in people with highly active relapsing-remitting multiple sclerosis. The study will evaluate the following items:\n\n1. Disease activity\n2. Safety and tolerability of aHSCT\n3. Changes in the immune system\n\nParticipants will be subjected to frequent visits for five years after treatment with aHSCT. During these visits, clinical testing, evaluation by questionnaires, MRI scans and blood sampling will be performed.",[30],"2024-08-19",{"date":438,"type":45},"2024-08-22",{"date":440,"type":45},"2023-08-25",{"date":442,"type":22},"2028-09-01",{"name":444,"class":52},"Amsterdam UMC, location VUmc",2,{"id":447,"slug":448,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":122,"enrollmentInfo":454,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":463,"locationsCount":53},"100555774","development-of-camera-based-gait-quality-measure-for-persons-with-multiple-sclerosis-100555774","NCT06516458","Development of Camera Based Gait Quality Measure for Persons With Multiple Sclerosis","Development of Camera Based Gait Deviation Index for Persons With Multiple Sclerosis","MS-GDI","Inclusion criteria:\n\n* Diagnosis of relapsing form of MS (including relapsing-remitting MS and secondary progressive MS)\n* Able to ambulate overground\n* Relapse free for at least 1 month\n* Age ≥18 and ≤ 75 years\n* Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening\n\nExclusion criteria:\n\n\\- Orthopedic injuries, fractures, surgeries or other conditions affecting locomotor function or weight bearing",{"count":335,"type":22},"The purpose of this study is to develop a measurement of walking quality, called Gait Deviation Index (GDI) for people with Multiple Sclerosis (MS).",[100,129,33,30],"2024-07-18",{"date":459,"type":45},"2024-07-24",{"date":461,"type":22},"2024-07",{"date":300,"type":22},{"name":141,"class":52},{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":361,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":474,"conditions":475,"keywords":482,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":53},"100454970","ms-researchbiomarkers-100454970","NCT05204459","MS-ResearchBiomarkerS","Investigating the Longitudinal Relationships Between Visual Pathway Injury, Radiological and Blood Biomarkers in Multiple Sclerosis and Related Disorders","MS-ReBS","Inclusion Criteria:\n\n* Subjects who meet any one of the following diagnostic criteria:\n\n  * Diagnosis of MS, CIS,or RIS based on the 2017 revised McDonald criteria.\n  * Diagnosis of NMOSD based on the 2015 revised NMOSD consensus diagnostic criteria.\n  * Diagnosis of myelin oligodendrocyte glycoprotein (MOG)-related encephalomyelitis, optic neuritis, or other associated disease.\n  * Diagnosis of neurological disorders other than MSRD.\n  * Healthy volunteer.\n* Age ≥18.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Patients will be excluded from the MRI portions of the study if they have a contraindication to MRI(metallic implantsor foreign bodies, claustrophobia, MRI-incompatible pacemakers, MRI- incompatible prosthetic heart valves).\n* Patients will be excluded from the MRI portions of the study if they are pregnant, but their demographic, clinical information,and disability measures may still be captured under the study.\n* Patients will be excluded from the visual assessment portions of the study if they have had any recent ocular surgery (within the past two months), refractive errors of greater than or equal to ±6 diopters or other eye diseases that may affect or confound OCT\u002FOCTA measurements (ex., age-related macular degeneration, advanced geographic atrophy, diabetic retinopathy, glaucoma).",{"count":473,"type":22},1000,"This study is being conducted to investigate risk factors for disability progression in Multiple Sclerosis and related disorders (MSRD). The primary goal is to assess whether combining information from visual assessment, blood markers, as well as historical and ongoing longitudinal MRIs of the brain, orbit (the part of the skull where eyes are located), and\u002For spinal cord can predict changes in quantitative disability measures related to MSRD and neurological disease.",[100,30,31,129,210,476,477,478,479,480,481],"Radiologically Isolated Syndrome","Neuromyelitis Optica Spectrum Disorders","Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease","Neurologic Autoimmune Disease","Neurologic Disorder","Healthy Aging",[100,30,31,129,210,476,477,483,479,480,481],"Myelin oligodendrocyte glycoprotein antibody-associated disease","2024-02-05",{"date":486,"type":45},"2024-02-06",{"date":488,"type":45},"2021-11-11",{"date":490,"type":22},"2041-11-11",{"name":492,"class":52},"Cedars-Sinai Medical Center",{"id":494,"slug":495,"hasResults":11,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":11,"sex":17,"minAge":501,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":504,"conditions":505,"keywords":506,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":53},"100531131","biomarkers-of-ahsct-100531131","NCT06195800","Biomarkers of aHSCT","Identifying Immune Biomarkers of Disease and Disease Control in Autoimmune Neurological Disease Using Autologous Haematopoietic Stem Cell Transplantation","BIO-MS","Inclusion Criteria:\n\n1. Diagnosis of a immune mediated neurological disease according to disease specific criteria (active treatment arm) or diagnosis of relapsing remitting multiple sclerosis (control arm).\n2. Treatment with autologous haematopoetic stem cell transplantation (active treatment arm) or high efficacy disease modifying treatment (control arm).\n3. Willing to provide biological samples for analysis and undergo clinical assessments for the duration of follow up.\n4. Able to understand English and provide informed consent.\n\nExclusion Criteria:\n\n1\\. Inability to provide informed consent.","16 Years",{"count":503,"type":22},15,"The underlying disease mechanisms which occur in patients with immune mediation neurological diseases, such as Multiple Sclerosis (MS), are incompletely understood. For such patients, autologous haematopoietic stem cell transplantation (aHSCT) has been increasingly used as a highly successful one-off treatment for some patients. This treatment aims to delete the faulty immune system with a course of chemotherapy and then 'reboot' the immune system using a patients' own stem cells (a cell with the unique ability of being a building block to create many different cells in the body) to stop further damage. Over the last 20 years more than 1800 patients with MS have been treated in Europe with high levels of success. It may be more successful than disease modifying treatment but unfortunately, a small portion of people do not respond to this treatment optimally and continue to accumulate disability. There is a risk of side effects, restricted largely to the time of treatment, which necessitates the need to ensure appropriate patients are treated. Whilst aHSCT is a very effective therapy, it is still in its early phase of development, is not in widespread use, and there is incomplete knowledge regarding how it works and importantly, why it does not work in some patients, and how to monitor response to treatment.\n\nUnfortunately, there is no way of detecting which patients will, and will not, benefit from the different treatments available or a way of monitoring the immune system to ensure further treatment is provided before irreversible damage occurs.\n\nThis study will investigate the immune system which is found in the fluid surrounding the brain and spinal cord, blood and stool of patients undergoing aHSCT and compare it to those receiving disease modifying treatment. This study will therefore further the understanding of biomarkers of aHSCT to develop an awareness of how it can be refined, may improve monitoring of patients following treatment and permit the development of markers which can predict potential treatment success or failure before patients are exposed to the risks.",[30],[37,507,508],"aHSCT","Autologous haematopoetic stem cell transplantation","2024-01-04",{"date":511,"type":45},"2024-01-08",{"date":513,"type":45},"2023-08-09",{"date":515,"type":22},"2026-08-09",{"name":517,"class":52},"Sheffield Teaching Hospitals NHS Foundation Trust",{"id":519,"slug":520,"hasResults":11,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":526,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":53},"100478503","multiparametric-assessment-to-investigate-prognostic-factors-for-disease-evolution-a-nd-evolutionary-patterns-of-cognitive-status-in-rrms-100478503","NCT05510817","Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS","Multiparametric Clinical, Radiological, Neuropsychological, and Neurophysiological Assessment to Investigate Prognostic Factors for Disease Evolution and Treatment Response in MS: a Prospective Study.","COGNIT-MS","Inclusion Criteria:\n\n* active MS, according to the Lublin criteria\n* disease duration \\\u003C 10 years before initiating or changing a disease-modifying therapies,\n* relapse- and steroid-free for at least 1 month before MRI acquisition\n* between 18-50 years old\n* having given informed consent\n* with no significant comorbidity other than MS or substance abuse that could interfere with cognitive performances\n\nExclusion Criteria:\n\n* progressive forms of MS","50 Years",{"count":363,"type":22},[66],"This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline.",[30],[532,533,534,535],"MRI","evoked potentials","cognitive function","PROMs","2023-12-03",{"date":538,"type":45},"2023-12-05",{"date":540,"type":45},"2022-06-06",{"date":542,"type":22},"2026-06-06",{"name":544,"class":52},"University Hospital of Mont-Godinne",{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":555,"briefSummary":556,"conditions":557,"keywords":562,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":53},"100503407","phase-3-non-inferiority-study-of-rituximab-compared-to-ocrelizumab-in-relapsing-ms-100503407","NCT05834855","Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS","Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing Multiple Sclerosis","Noisy Rebels","Inclusion Criteria:\n\n1. Men and women aged 18 years and older\n2. A diagnosis of relapsing MS according to the 2017 revised diagnostic criteria\n3. Indication to start treatment with anti-CD20 therapy according to the treating neurologist and the relevant label in the Netherlands for treatment of relapsing MS\n4. Able to understand written and spoken Dutch or English\n5. Capable of giving signed informed consent including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n6. Screening EDSS score ≤ 6.5 .\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. A known allergy or other intolerability to RTX, OCR, gadolinium-based MRI contrast agents, or corticosteroids.\n2. A diagnosis of primary progressive MS according to the diagnostic criteria.\n3. A diagnosis of not-active secondary progressive MS.\n4. Chronic infectious diseases such as tuberculosis, VZV, hepatitis virus or HIV, as well as hepatitis B surface antigen positivity and\u002For hepatitis C PCR positivity verified at screening visit.\n5. A history of proven inflammatory bowel disease such as M. Crohn or ulcerative colitis\n6. Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.\n7. Cardiac disease that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC\n8. Active malignancy or prior history of malignancy that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC.\n9. WBC \\\u003C 1.5 x 109\u002FL if not caused by a reversible effect of documented ongoing medication. If caused by a reversible effect of documented ongoing medication the WBC count must be \\> 1,5 x 109\u002FL before start of study treatment.\n10. Platelet (thrombocyte) count \\\u003C 100 x 109\u002FL\n11. ALAT and\u002For ASAT more than 2 times the upper normal reference limit (ULN)\n12. Serum creatinine \\> 200 μmol\u002FL\n13. Serum bilirubin \\> ULN\n14. Serum IgG \\\u003C LLN\n15. Pregnant or breast-feeding women\n16. Women of childbearing potential (WOCBP) not able or willing to use highly effective methods of birth control per ICH M3 (R2) that result in failure rate of ≤ 1% per year when used consistently and correctly for the duration of the study OR until 3 months after last dose administered.\n17. History of serious or life-threatening infusion reaction to OCR or RTX\n18. Treatment with glucocorticoids or ACTH within one month prior to start of study treatment\n\n    Prior\u002FConcomitant Therapy\n19. Previous use of second line MS-therapies cladribine, RTX, alemtuzumab, OCR, ofatumumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression therapies with long lasting effects. Mitoxantrone is allowed if used \\> 1 year before enrolment. If any of these medications have been used for indications other than MS, patients can be included if the medications have not been used the year before enrolment. Previous treatment with natalizumab is allowed if the reason to switch was disease activity (so not allowed in for example cases that switch from natalizumab to anti-CD20 therapy because of JCV positivity).\n20. Concomitant use of systemic immunosuppressive medication (except corticosteroids for symptomatic treatment of relapses).\n\n    Prior\u002FConcurrent Clinical Study Experience\n21. Currently enrolled in another investigational device or drug study, or less than 30 days since ending of another investigational device or drug study (s), or receiving other investigational treatment(s). Patients participating in a purely observational studies will be allowed to participate.\n\n    Lifestyle\n22. Current alcohol or drug dependencies.\n\n    Diagnostic assessments\n23. Presence of metallic objects implanted in the body, that would preclude the ability of the patient to safely have MRI exams.\n24. Not willing to undergo MRI scans with i.v. gadolinium injections",{"count":554,"type":22},200,[96],"Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the treatment of RMS. An advantage of rituximab is a considerably lower price. Therefore we will start a study aimed at demonstrating non-inferiority of rituximab compared to ocrelizumab in RMS. If non-inferiority of rituximab can be shown, important reductions in the cost of treatment of RMS will be possible, without loss of efficacy.\n\nObjective: Evaluating the efficacy and safety of ritixumab compared to ocrelizumab in the treatmens of RMS.\n\nStudy design: Randomized double blind multi-centre non-inferiority study of rituximab compared to ocrelizumab in 200 patients with RMS. The trial duration will be 30 months\n\nStudy population: The study population consists of 200 adult RMS patiens with an indication to start anti-CD20 monoclonal antibody treatment.\n\nIntervention: Patients will be randomized 1:1 into the standard group (ocrelizumab treatment) or the experimental group (rituximab treatment).\n\nMain study parameters: To conclude non-inferiority of rituximab there will be one primary endpoint: the proportion of patients free of inflammatory disease activity (defined as: new or enlarged T2 lesions) between week 24 (M6) and week 96 (M24) of treatment in each arm. Secondary trial endpoints are presence and number of clinical relapses,T2 and contrast enhancing lesion volumes, brain volume and brain volume changes, disease progression (defined as clinically relevant change on any of the measures: EDSS, T25FW, 9HPT, SDMT), biochemical parameters such as lipidomics and neurofilament light (NfL), immunological parameters, safety as measured by the number of (serious) adverse events ((S)AE), quality of life (EQ-5D-L) and treatment satisfaction (TSQM) and patient reported measures of MS impact (MSIS-29) and well-being (questionnaire on physical complaints)\n\nNature and extent of the burden and risk: Patients included in this study will be treated and monitored by MRI, clinical tests and laboratory tests according to existing protocols and will not be exposed to extra or unknown risks. They will have extra annual questionnaires and larger blood samples at some time points. There is extensive experience with both rituximab and ocrelizumab as efficacious and safe treatments of RMS.",[100,30,558,559,560,561],"Demyelinating Autoimmune Diseases, CNS","Autoimmune Diseases of the Nervous System","Nervous System Diseases","Demyelinating Diseases",[563,564,565],"ocrelizumab","rituximab","non-inferiority","2023-04-17",{"date":568,"type":45},"2023-04-28",{"date":570,"type":22},"2023-04",{"date":572,"type":22},"2027-05",{"name":444,"class":52},{"id":575,"slug":576,"hasResults":11,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":384,"enrollmentInfo":581,"targetDuration":4,"studyType":207,"phases":4,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":53},"100397712","investigating-the-effect-of-ocrelizumab-in-african-americans-and-caucasians-with-relapsing-multiple-sclerosis-100397712","NCT04458688","Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis","Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) Study","Inclusion Criteria:\n\n1. Patients who have chosen to start ocrelizumab and for whom ocrelizumab is determined to be the most appropriate standard-of-care disease modifying therapy (DMT) by the treating neurologist.\n2. May be treatment naive, or had suboptimal response to no more than one DMT after an adequate course of treatment (defined as treatment duration of 6+ months).\n3. Age 18 to 60 years old.\n4. Ethnicity: self-identified as African American or Caucasian.\n5. Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised McDonald criteria.\n6. EDSS from 0 to 6 (inclusive) at baseline visit.\n7. Able to give informed consent.\n8. Able to have MRI scans.\n\nExclusion Criteria:\n\n1. Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab.\n2. Failed 2 or more DMTs.\n3. Treatment with immunosuppressant agents, such as chemotherapeutic agents.\n4. Claustrophobia.\n5. Allergy to contrast.\n6. Significant medical problems that the PI determines will interfere with the conduct of the study.\n7. Relapse or use of corticosteroids within 30 days prior to baseline visit.\n8. Pregnancy.\n9. History of kidney or liver insufficiency.\n10. History of malignancy.",{"count":582,"type":22},80,"The investigators intend to examine the effects of ocrelizumab use in African American multiple sclerosis disease course compared to Caucasian disease course utilizing imaging measures with magnetic resonance imaging (MRI) and optical coherence tomography angiography (OCT-A)..",[30],[37,563,586,587],"magnetic resonance imaging (MRI)","optical coherence tomography angiography (OCTA)","2022-06-03",{"date":540,"type":45},{"date":591,"type":45},"2021-11-20",{"date":593,"type":22},"2030-12",{"name":595,"class":52},"Wayne State University"]