What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) with properties similar to Clemastine Fumarate include fingolimod, dimethyl fumarate, and glatiramer acetate. Fingolimod can cause headache, elevated liver enzymes, diarrhea, cough, flu-like symptoms, and has serious risks like bradyarrhythmia, macular edema, and increased infection risk. Dimethyl fumarate's side effects include flushing, gastrointestinal issues, and a potential decrease in lymphocyte counts. Glatiramer acetate may cause injection site reactions, chest pain, and lipoatrophy. These treatments aim to modify the disease course and manage symptoms, but they come with a range of potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

Clemastine Fumarate is being studied for its potential remyelinating properties in MS patients. While no other FDA-approved treatments specifically target remyelination through antimuscarinic properties, several disease-modifying therapies (DMTs) are approved for MS. These include glatiramer acetate, which modulates the immune response to myelin, and dimethyl fumarate, which has neuroprotective and anti-inflammatory effects. Both drugs aim to reduce relapse rates and slow disease progression, though they do not directly promote remyelination.

What other types of research exist?

Promising novel alternatives to Clemastine Fumarate for Multiple Sclerosis patients include: <ol> <li>Masitinib: A selective oral tyrosine kinase inhibitor that targets mast cells and microglia, showing neuroprotective effects by reducing neuroinflammation and slowing disease progression.</li> <li>Neurotrophic factor (NTF)-secreting mesenchymal stromal cells (MSC-NTF cells): Stem cell therapy that has shown potential in early clinical trials for improving disease progression rates.</li> <li>Dimethyl Fumarate (DMF): An oral medication that has demonstrated efficacy in reducing relapse rates and new brain lesions in MS patients, with ongoing studies to further validate its effectiveness.</li> </ol>

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Antihistamine

Clemastine Fumarate for Multiple Sclerosis (ReVIVE Trial)

Q: What is the mechanism of action of this treatment?

Clemastine Fumarate, an antimuscarinic agent, promotes remyelination by potentially enhancing the repair of myelin sheaths damaged by MS. This is significant as no current therapies specifically target myelin repair. Other common treatments for MS, such as interferon beta and glatiramer acetate, work by modulating the immune response to reduce inflammation and prevent further damage to the nervous system. Dimethyl fumarate, another DMT, has anti-inflammatory and neuroprotective effects. These mechanisms are crucial for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression, thereby improving quality of life.

Phase 1 & 2

Recruiting

Led By Ari J Green, MD, MCR

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)

Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of < 15 years

Must not have

History of significant cardiac conduction block

Treatment with corticosteroids within 30 days prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be assessed at the 6-month visit.

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial tests Clemastine Fumarate to see if it can repair myelin in patients with relapsing-remitting multiple sclerosis who have chronic brain lesions. The medication helps immature brain cells develop into myelin-producing cells, potentially fixing the damage caused by MS.

Who is the study for?

This trial is for adults aged 18-55 with relapsing-remitting multiple sclerosis (MS) diagnosed within the last 15 years. Participants must use effective birth control and provide informed consent. Excluded are those with recent MS lesions, hypersensitivity to clemastine, steroid treatment within 30 days, cancer history, suicidal behavior in past 6 months, pregnancy or breastfeeding intentions, other concurrent study involvement without approval.

What is being tested?

The trial tests Clemastine Fumarate as a potential myelin repair therapy against a placebo in MS patients. It measures changes using multi-parametric MRI and a new technique called Ultrashort Echo Time (UTE) MRI to assess remyelination of chronic brain lesions.

What are the potential side effects?

Potential side effects include typical antihistamine reactions like drowsiness or dry mouth. Since it's an investigational therapy for MS remyelination, there may be unknown risks or side effects that will be monitored throughout the study.

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.

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

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I have been post-menopausal for at least one year.

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I am using a reliable birth control method during the study.

Exclusion Criteria

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

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I have a history of serious heart rhythm problems.

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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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My kidney and liver tests show higher than normal results.

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I have not treated my B12 deficiency or hypothyroidism.

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My disability level is moderate to severe.

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I have had treatments like lymph node radiation or T cell vaccines.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be assessed at the 6-month visit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be assessed at the 6-month visit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be assessed at the 6-month visit. 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 T1 Relaxation Time at 3 Months

+39 more

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, then Clemastine 8 mgExperimental Treatment2 Interventions

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

Group II: Clemastine 8 mg, then PlaceboExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Clemastine Fumarate, an antimuscarinic agent, promotes remyelination by potentially enhancing the repair of myelin sheaths damaged by MS. This is significant as no current therapies specifically target myelin repair. Other common treatments for MS, such as interferon beta and glatiramer acetate, work by modulating the immune response to reduce inflammation and prevent further damage to the nervous system. Dimethyl fumarate, another DMT, has anti-inflammatory and neuroprotective effects. These mechanisms are crucial for MS patients as they help manage symptoms, reduce relapse rates, and slow disease progression, thereby improving quality of life.

Mode of action and clinical studies with alemtuzumab.[Fumaric acid as therapeutic agent for multiple sclerosis].