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.
Age range
18 Years – 55 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Corpus Callosum Myelin Water Fraction
Timeframe: This will be assessed at the baseline visit.
Change from Baseline in Corpus Callosum Myelin Water Fraction at 3 Months
Timeframe: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corpus Callosum Myelin Water Fraction at 6 Months
Timeframe: This will be assessed at the baseline and 6-month visits.
Corpus Callosum T1 Relaxation Time
Timeframe: This will be assessed at the baseline visit.
Change from Baseline in Corpus Callosum T1 Relaxation Time at 3 Months
Timeframe: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corpus Callosum T1 Relaxation Time at 6 Months
Timeframe: This will be assessed at the baseline and 6-month visits.
Corpus Callosum UTE Fraction
Timeframe: This will be assessed at the baseline visit.
Change from Baseline in Corpus Callosum UTE Fraction at 3 Months
Timeframe: This will be assessed at the baseline and 3-month visits.
Change from Baseline in Corpus Callosum UTE Fraction at 6 Months
Timeframe: This will be assessed at the baseline and 6-month visits.