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Myelin Repair Therapy for Multiple Sclerosis (ReINFORCE Trial)

Phase 1 & 2

Waitlist Available

Led By Ari J Green, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female patients aged 18-55 years (inclusive)

Be between 18 and 65 years old

Must not have

Treatment with corticosteroids within 30 days prior to screening

History of cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be assessed at the baseline and 6-month visits.

Summary

This trial will assess the effects of clemastine fumarate to repair/protect brain lesions in people with acute demyelination, using MRI assessments and a new technique called Ultrashort Echo Time (UTE) MRI.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Clemastine may cause drowsiness, dry mouth, blurred vision, constipation, and difficulty urinating. It might also lead to hypersensitivity reactions in those allergic to arylalkylamine antihistamines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken corticosteroids in the last 30 days.

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I have had cancer in the past.

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I have had treatments targeting my immune system.

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I have been treated with alemtuzumab, mitoxantrone, or cyclophosphamide.

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My disability level is moderate to severe.

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I have a history of serious heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be assessed at the baseline and 6-month visits.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be assessed at the baseline and 6-month visits.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be assessed at the baseline and 6-month visits. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Corpus Callosum Myelin Water Fraction at 3 Months

Change from Baseline in Corpus Callosum Myelin Water Fraction at 6 Months

Change from Baseline in Corpus Callosum T1 Relaxation Time at 3 Months

+6 more

Secondary study objectives

Change from Baseline in Clemastine Tolerability at 3 Months

Change from Baseline in Clemastine Tolerability at 6 Months

Change from Baseline in Corticospinal Tract Myelin Water Fraction at 3 Months

+36 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, then Clemastine 12 mg, then Clemastine 8 mgExperimental Treatment2 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 PlaceboExperimental Treatment2 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 7Eligibility criteria met