Micropillar arrays as a high-throughput screening platform for therapeutics in multiple sclerosis.
Feng Mei, Stephen P J Fancy, Yun-An A Shen...
https://pubmed.ncbi.nlm.nih.gov/24997607Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 55Years
All Genders
ID05359653
A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess Changes in MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
Led by University of California, San Francisco · Updated on 2026-03-11
74
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying clemastine fumarate as a potential therapy to repair damaged myelin in patients with relapsing-remitting multiple sclerosis (MS). This clinical trial aims to evaluate clemastine's protective and reparative effects on chronic demyelinating brain lesions using advanced multi-parametric MRI scans. The study builds on previous research that showed promising signs of clemastine promoting myelin repair in MS patients with optic neuropathy. The University of California, San Francisco is leading this randomized, placebo-controlled trial to better understand MRI markers for myelin recovery and guide future remyelinating treatments. Participants will be randomly assigned to one of two groups. One group will take 8 mg of clemastine daily for the first 90 days followed by placebo pills for the next 90 days, while the other group will start with placebo and then switch to clemastine for the second 90 days. The study uses a double-blind design where neither participants nor researchers know the treatment order. The study lasts six months, with treatment phases and MRI assessments planned at baseline, three months, and six months. The trial also evaluates the tolerability of clemastine and compares a novel MRI technique called Ultrashort Echo Time (UTE) MRI with conventional scans to measure myelin repair. During the study, participants will undergo several MRI scans focusing on the corpus callosum and other brain regions to assess changes in myelin water fraction, T1 relaxation times, and UTE fractions. These measurements will be taken at baseline, three months, and six months to track potential remyelination. Additional clinical assessments include monitoring adverse events and tolerability of clemastine. The total participation period is six months, with regular follow-up visits for MRI imaging and clinical evaluations to measure outcomes related to myelin recovery and treatment safety.
CONDITIONS
Brief Title
Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
Who Can Participate
Age: 18Years - 55Years
All Genders
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before any assessments
- Diagnosed with relapsing remitting multiple sclerosis with disease duration less than 15 years
- Male or female aged 18 to 55 years inclusive
- Women must use appropriate contraception or meet specific criteria regarding fertility status during the study period
You will not qualify if you...
- MRI shows significant brain atrophy for age
- New lesion on MRI within the last 3 months
- Hypersensitivity to clemastine or related antihistamines
- Use of corticosteroids within 30 days before screening
- Expanded Disability Status Scale score of 4.5 or higher
- History of significant heart conduction block or cancer
- Suicidal thoughts or behavior within 6 months before baseline
- Pregnant, breastfeeding, or planning pregnancy
- Participation in other studies without approval
- Using other remyelinating therapies
- Prior treatment with certain immunotherapies or radiation
- Elevated kidney or liver function tests within 72 hours
- History of drug or alcohol abuse within past year
- Untreated vitamin B12 deficiency or hypothyroidism
- Major medical illnesses affecting safety or study interpretation
- Unable to undergo MRI due to claustrophobia or metal in jaw/face
- Any clinically significant medical illness or lab abnormality preventing participation according to investigator judgment
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 6 months
Participants receive either Clemastine Fumarate or placebo for 90 days, then switch to the alternate treatment for another 90 days in a crossover design.
Baseline visit and visits at 3 months and 6 months
Trial Site Locations
Total: 1 location
1
Sandler Neurosciences Building, Neurological Clinical Research Unit
San Francisco, California, United States, 94107
Actively Recruiting
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Research Team
H
Harkeerat Halait, BS
A
Angelica Montevirgen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
MP2RAGE, a self bias-field corrected sequence for improved segmentation and T1-mapping at high field.
José P Marques, Tobias Kober, Gunnar Krueger...
https://pubmed.ncbi.nlm.nih.gov/19819338Magnetic resonance imaging of myelin using ultrashort Echo time (UTE) pulse sequences: Phantom, specimen, volunteer and multiple sclerosis patient studies.
Vipul Sheth, Hongda Shao, Jun Chen...
https://pubmed.ncbi.nlm.nih.gov/27155128Clemastine fumarate as a remyelinating therapy for multiple sclerosis (ReBUILD): a randomised, controlled, double-blind, crossover trial.
Ari J Green, Jeffrey M Gelfand, Bruce A Cree...
https://pubmed.ncbi.nlm.nih.gov/29029896Motor evoked potentials in multiple sclerosis patients without walking limitation: amplitude vs. conduction time abnormalities.
Andrea Gagliardo, Francesca Galli, Antonello Grippo...
https://pubmed.ncbi.nlm.nih.gov/17308868