Actively Recruiting
Assessing Changes in Multi-parametric 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
147 weeks
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
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. No 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. This 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. In 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.
CONDITIONS
Official Title
Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent must be obtained prior to any assessment being performed.
- Diagnosed with relapsing-remitting multiple sclerosis with disease duration less than 15 years.
- Male or female aged 18 to 55 years inclusive.
- Women must be post-menopausal for at least 1 year, surgically sterile, practicing highly effective birth control if sexually active, not heterosexually active or practicing true abstinence during the study.
- Use of appropriate contraception during the trial period (women).
You will not qualify if you...
- Marked brain atrophy relative to age on recent MRI.
- New lesion on MRI within 3 months before screening.
- Allergic to clemastine, arylalkylamine antihistamines, or any excipients.
- Corticosteroid treatment within 30 days prior to screening.
- Expanded Disability Status Scale (EDSS) score of 4.5 or higher.
- History of significant cardiac conduction block.
- History of cancer.
- Suicidal ideation or behavior in past 6 months.
- Pregnancy, breastfeeding, or planning pregnancy.
- Participation in other studies without approval.
- Use of other remyelinating therapies.
- Prior treatment with total lymphoid irradiation, T cell or T cell receptor vaccination.
- Prior treatment with alemtuzumab, mitoxantrone, or cyclophosphamide.
- Serum creatinine greater than 1.5 mg/dL or liver enzymes more than twice normal.
- History of drug or alcohol abuse within past year.
- Untreated vitamin B12 deficiency or hypothyroidism.
- Significant medical illnesses affecting safety or study results.
- Inability to undergo MRI (e.g., extreme claustrophobia).
- Presence of dental braces or permanent metals in jaw or face.
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Trial Site Locations
Total: 1 location
1
Sandler Neurosciences Building, Neurological Clinical Research Unit
San Francisco, California, United States, 94107
Actively Recruiting
Research Team
H
Harkeerat Halait, BS
CONTACT
A
Angelica Montevirgen
CONTACT
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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