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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

ReINFORCE Trial 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.Check my eligibility

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.See study design

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.

ReINFORCE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 55 years old.

ReINFORCE Trial 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

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 more

Secondary 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 Tract Myelin Water Fraction at 3 Months

+36 more

ReINFORCE 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,511 Total Patients Enrolled

23 Trials studying Multiple Sclerosis

2,486 Patients Enrolled for Multiple Sclerosis

Ari J Green, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the cut-off age for this research project below 45 years old?

"The target demographic for this trial is adults aged 18-55."

Answered by AI

Are there any restrictions on who can participate in this clinical experiment?

"The qualifications to join this clinical trial include being between 18 and 55 years of age, and having an existing diagnosis of multiple sclerosis. A total of 44 participants are sought for the experiment."

Answered by AI

Are there any openings in this research experiment at present?

"The clinicaltrial.gov website confirms that this medical study, which was initially published on November 1st 2023, is presently not looking for new participants. However, there are 543 other trials actively seeking patients at the moment."

Answered by AI

What are the ultimate aims of this experiment?

"This trial's primary outcome is the alteration to Corpus Callosum Myelin Water Fraction (MWF) at 3 months, while secondary objectives include assessment of Optic Radiation MWF and Corticospinal Tract MWF. All changes will be measured against baseline values established upon entering the study."

Answered by AI

Recent research and studies

Nature MedicineJournal

Micropillar Arrays as a High-throughput Screening Platform for Therapeutics in Multiple Sclerosis

Mei, Feng, Stephen P J Fancy, Yun-An A Shen, Jianqin Niu, Chao Zhao, Bryan Presley, Edna Miao, et al.. 2014. “Micropillar Arrays as a High-throughput Screening Platform for Therapeutics in Multiple Sclerosis”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/nm.3618.

NeuroImageJournal

MP2RAGE, a Self Bias-field Corrected Sequence for Improved Segmentation and T1-mapping at High Field

Marques, José P., Tobias Kober, Gunnar Krueger, Wietske van der Zwaag, Pierre-François Van de Moortele, and Rolf Gruetter. 2010. “MP2RAGE, a Self Bias-field Corrected Sequence for Improved Segmentation and T1-mapping at High Field”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2009.10.002.

NeuroImageJournal

Magnetic Resonance Imaging of Myelin Using Ultrashort Echo Time (UTE) Pulse Sequences: Phantom, Specimen, Volunteer and Multiple Sclerosis Patient Studies

Sheth, Vipul, Hongda Shao, Jun Chen, Scott Vandenberg, Jody Corey-Bloom, Graeme M. Bydder, and Jiang Du. 2016. “Magnetic Resonance Imaging of Myelin Using Ultrashort Echo Time (UTE) Pulse Sequences: Phantom, Specimen, Volunteer and Multiple Sclerosis Patient Studies”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2016.05.012.

clinicaltrials.govStudy