[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-sclerosis-acute-and-progressive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-sclerosis-acute-and-progressive":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"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":34,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100521136","phase-1-assessing-changes-in-multi-parametric-mri-in-patients-with-acute-demyelinating-lesions-taking-clemastine-fumarate-as-a-myelin-repair-therapy-100521136",false,"NCT06065670","Assessing Changes in Multi-parametric MRI in Patients With Acute Demyelinating Lesions 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 Patients With Acute Demyelinating Lesions Taking Clemastine Fumarate as a Myelin Repair Therapy","ReINFORCE","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},44,"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 acute inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments.\n\nNo reparative therapies exist for the treatment of acute demyelinating lesions. 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 acute 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 lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination.\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 acute lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination and compare it to the other assessments.",[29,30,31,32,33],"Demyelinating Diseases","Demyelination; Corpus Callosum","Multiple Sclerosis Brain Lesion","Multiple Sclerosis Acute and Progressive","Clinically Isolated Syndrome, CNS Demyelinating",[35,36,37,38,39],"acute brain lesions","mri","brain","demyelinating lesions","spinal cord","NOT_YET_RECRUITING","2026-03-09",{"date":43,"type":44},"2026-03-11","ACTUAL",{"date":46,"type":22},"2026-09-15",{"date":48,"type":22},"2028-10-30",{"name":50,"class":51},"University of California, San Francisco","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"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":73,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":52},"100620266","home-based-functional-balance-intervention-for-multiple-sclerosis-100620266","NCT07355387","Home Based Functional Balance Intervention for Multiple Sclerosis","Home Based Functional Balance Intervention (FBI) for Physical and Cognitive Symptoms of Multiple Sclerosis","HomeFBIinMS","Inclusion Criteria\n\nTelephone Screening Inclusion Criteria:\n\n1. Age 40-90 years.\n2. Self-reported diagnosis of Multiple Sclerosis.\n3. On stable disease-modifying therapy for ≥6 months.\n4. No PT\u002FOT balance-related therapy in the past 6 months.\n5. Able to stand from a chair independently (with or without hand support).\n6. Score 25-75% on the 12-item MS Walking Scale.\n7. No other neurological, cardiopulmonary, musculoskeletal, or systemic conditions affecting standing\u002Fwalking.\n8. English speaking.\n9. Willing to complete all study procedures including Zoom sessions.\n10. Has reliable internet access.\n11. Has a helper buddy available for all sessions.\n12. Possible mild cognitive impairment based on self-report.\n\nInitial Screening Inclusion Criteria:\n\n1. Moderate disability: ePR-EDSS score 4.0-6.5.\n2. Mild cognitive impairment: MoCA 18-25, or Jak\u002FBondi criteria for those scoring 26-30.\n3. Physically inactive or moderately active (Godin score \\\u003C24).\n4. Cardiovascular safety parameters within acceptable limits.\n5. No global aphasia (Mississippi Aphasia Screening Test ≥71 percent).\n6. Berg Balance Scale score ≥40\u002F56.\n7. Able to walk 1 block with or without an assistive device.\n\nHelper Buddy Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Lives within close proximity to the participant.\n3. No self-reported major medical conditions limiting safety assistance.\n4. English speaking.\n5. Able to attend all training and assessment sessions.\n6. Able to assist with basic safety, positioning, and communication with the research team.\n7. Has internet access and can use Zoom.\n\nExclusion Criteria\n\nTelephone Screening Exclusion Criteria:\n\n1. MS relapse or exacerbation within the past 3 months.\n2. Recent major surgery (\\\u003C6 months) or hospitalization (\\\u003C3 months).\n3. Resting shortness of breath or uncontrolled pain \\>3\u002F10.\n4. Uncontrolled hypertension or diabetes.\n5. Bone fracture in the past 6 months.\n6. Disability limiting activities of daily living.\n7. History of epilepsy or uncontrolled seizures in past year.\n8. Sedative medication use that may interfere with training.\n9. Use of Alzheimer's\u002Fdementia-modifying drugs or enrollment in AD clinical trials.\n10. Use of antidepressants or anxiety medications.\n11. Moderate or high risk on PAR-Q (≤1 \"yes\" response).\n12. Severe cognitive impairment (TICS-M ≥18).\n13. Currently receiving cognitive or physical rehabilitation.\n14. Pacemaker use.\n\nInitial Screening Exclusion Criteria:\n\n1. Cardiovascular parameters outside safety limits (HR, BP, O₂ saturation).\n2. Global aphasia (Mississippi \\\u003C71 percent).\n3. Peripheral nerve injury.\n4. Berg Balance Scale \\\u003C40\u002F56.\n5. Inability to walk one block with or without an assistive device.\n\nPopulation Exclusions:\n\n1. Non-English speakers (protocol delivered only in English).\n2. Individuals under 18 years.\n3. Pregnant individuals.\n4. Prisoners or other vulnerable populations.","40 Years","90 Years",{"count":64,"type":22},75,[66],"NA","The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS).\n\nCombined Specific Aims:\n\nAim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group).\n\nHypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group.\n\nAim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program.\n\nHypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group.\n\nAim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life).\n\nHypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group.\n\nAll assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy.\n\nThe investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.",[69,70,71,72,32],"Multiple Sclerosis","Multiple Sclerosis (MS) - Relapsing-remitting","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive",[74,75,69,76,77,78,79,80],"Home based rehabilitation","Telerehabilitation","Mild cognitive impairment","functional balance","safety monitoring","Cognitive motor training","vestibular training","RECRUITING","2026-01-12",{"date":84,"type":44},"2026-01-21",{"date":86,"type":44},"2025-11-24",{"date":88,"type":22},"2027-11-24",{"name":90,"class":51},"University of Illinois at Chicago"]