Myelin Repair Therapy for Multiple Sclerosis

(ReINFORCE Trial)

Overseen By Ari J Green, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?

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. No 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. This 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. 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 acute lesions found in patients with a confirmed diagnosis of acute inflammatory injury-causing demyelination and compare it to the other assessments.

Research Team

Ari J Green, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults aged 18-55 with relapsing-remitting multiple sclerosis and disease duration under 15 years. Participants must use effective birth control, not be pregnant or breastfeeding, and have no severe medical issues or recent drug/alcohol abuse. They can't have certain treatments like corticosteroids within the last month or a new lesion on their latest MRI.

Inclusion Criteria

Written informed consent must be obtained prior to any assessment being performed

I have relapsing-remitting MS diagnosed within the last 15 years.

I am between 18 and 55 years old.

Exclusion Criteria

Pregnancy, breastfeeding or planning to become pregnant

Any dental braces or permanent or undetachable metals in the jaw or face

I have not taken corticosteroids in the last 30 days.

Treatment Details

Interventions

• Clemastine Fumarate (Other)
• Placebo (Other)

Trial Overview The study tests Clemastine Fumarate as a potential myelin repair therapy against a placebo in patients with acute demyelinating brain lesions using advanced MRI techniques to measure its effects.

Participant Groups

Group I: Placebo, then Clemastine 12 mg, then Clemastine 8 mg Experimental Treatment 2 Interventions

Group 1 will receive the placebo for the first 90 days. Then, they will switch to clemastine (treatment) for 90 days. They will receive clemastine 12 mg for 14 days followed by clemastine 8 mg for the remaining 76 days.

Group II: Clemastine 12 mg, then clemastine 8 mg, then Placebo Experimental Treatment 2 Interventions

Group 1 will receive the treatment (clemastine) for the first 90 days. They will receive clemastine 12 mg for 14 days followed by clemastine 8 mg for 76 days, and then switch to the placebo (a sugar pill) for the remaining 90 days

Clemastine Fumarate is already approved in Canada for the following indications:

Approved in Canada as Clemastine for:

• Allergic rhinitis
• Urticaria
• Pruritus

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+