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Antihistamine
Clemastine Fumarate for Multiple Sclerosis (ReVIVE Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be assessed at the 6-month visit.
Awards & highlights
ReVIVE Trial Summary
This trial is testing whether Clemastine Fumarate can help repair myelin in patients with chronic demyelination as measured by MRI assessments.
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.Check my eligibility
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.See study design
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.
ReVIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
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I have relapsing-remitting MS diagnosed within the last 15 years.
Select...
I have been post-menopausal for at least one year.
Select...
I am using a reliable birth control method during the study.
ReVIVE Trial 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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreReVIVE 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
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
861 Previous Clinical Trials
227,120 Total Patients Enrolled
11 Trials studying Multiple Sclerosis
760 Patients Enrolled for Multiple Sclerosis
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,481 Total Patients Enrolled
23 Trials studying Multiple Sclerosis
2,456 Patients Enrolled for Multiple Sclerosis
Ari J Green, MD, MCRPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 55 years old.I have relapsing-remitting MS diagnosed within the last 15 years.I have been post-menopausal for at least one year.I have a history of serious heart rhythm problems.You have had issues with drugs or alcohol in the past year.I have not taken corticosteroids in the last 30 days.You have braces or permanent metal in your jaw or face.I have had cancer in the past.I am using a reliable birth control method during the study.I do not have any major health issues that could affect my safety or the study results.I am not using any other treatments for nerve repair as decided by my doctor.You are allergic to clemastine or similar types of antihistamines.My kidney and liver tests show higher than normal results.Your recent MRI shows significant brain shrinkage for your age, as confirmed by a specialist.You have had thoughts of hurting yourself or attempting suicide in the 6 months before the study starts.You cannot have an MRI because you are very afraid of small, enclosed spaces.I have not treated my B12 deficiency or hypothyroidism.My disability level is moderate to severe.I have had treatments like lymph node radiation or T cell vaccines.I practice true abstinence as a lifestyle choice.I have been treated with alemtuzumab, mitoxantrone, or cyclophosphamide.You have a new abnormality in your most recent MRI scan from the past 3 months.I am a woman considering participation.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo, then Clemastine 8 mg
- Group 2: Clemastine 8 mg, then Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to join this research study currently available?
"According to clinicaltrials.gov, this particular trial is not presently enlisting patients; the listing which was originally posted on 1st January 2023 has been updated most recently on 28th November 2022. However, there are currently 549 other trials actively enrolling participants."
Answered by AI
Is it possible for me to participate in this experiment?
"This clinical trial is seeking 74 individuals aged 18-55 with a diagnosis of relapsing remitting multiple sclerosis and an illness duration of under 15 years. In addition, the potential participants must provide written informed consent prior to any assessment being performed; they are required to abstain from heterosexual activity or use highly effective birth control methods if sexually active during their participation in the study; plus post-menopausal women should have been so for at least one year or be surgically sterile."
Answered by AI
What is the fundamental purpose of this trial?
"This trial's primary outcome measure is the Corpus Callosum Myelin Water Fraction which will be evaluated at baseline and 3-month visits. Secondary outcomes include Corticospinal Tract Myelin Water Fraction, Informative Outcomes at 3 Months, and Change from Baseline in Optic Radiation T1 Relaxation Time at 6 Months with change being calculated as (6-month % - Baseline %)."
Answered by AI
Does this experimental research encompass individuals over the age of fifty?
"This medical trial is seeking individuals who are within the 18 to 55 age range."
Answered by AI
Who else is applying?
What site did they apply to?
Sandler Neurosciences Building, Neurological Clinical Research Unit
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I truly believe that this new treatment may help people to improve some functions that they have lost. I want to be a part of such study which could help people with ms to recover.
PatientReceived 1 prior treatment
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