Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05359653
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Multiple Sclerosis (MS)
  • Multiple Sclerosis Benign
  • Multiple Sclerosis Brain Lesion
  • Multiple Sclerosis Relapse
  • Multiple Sclerosis, Chronic Progressive
  • Multiple Sclerosis, Primary Progressive
  • Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Clemastine Fumarate — DRUG
    8 mg Clemastine tablet. Clemastine fumarate was approved by the Food and Drug Administration (FDA) for the treatment of allergic rhinitis (seasonal allergies) in 1977 and was approved for over-the-counter marketing in 1992. Clemastine is not FDA approved as a remyelinating therapy
  • Placebo — DRUG
    Matched sugar tablet

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Mar 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Clemastine 8 mg, then Placebo
    Group 1 will receive the treatment (clemastine 8mg/day) for the first 90 days and then switch to the placebo (a sugar pill) for the remaining 90 days
  • Experimental: Placebo, then Clemastine 8 mg
    Group 2 will receive the placebo (a sugar pill) for the first 90 days and then switch to the treatment (clemastine 8mg/day) for the remaining 90 days

Primary Outcome Measure

Corpus Callosum Myelin Water Fraction [ Time Frame: This will be assessed at the baseline visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sandler Neurosciences Building, Neurological Clinical Research UnitSan FranciscoCalifornia94107
Harkeerat Halait, BS
[email protected]
415-745-1304
Angelica Montevirgen, BS
[email protected]
415-745-1304
Ari J Green, MD (PRINCIPAL_INVESTIGATOR)

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Sandler Neurosciences Building, Neurological Clinical Research Unit· San Francisco, CA

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