Clemastine Fumarate for Multiple Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sandler Neurosciences Building, Neurological Clinical Research Unit, San Francisco, CA
Multiple Sclerosis+7 More
Clemastine Fumarate - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

The clinical trial is intended to assess for clinical evidence of Clemastine Fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination as measured by multi-parametric MRI assessments. No reparative therapies exist for the treatment of multiple sclerosis. 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 chronic 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 chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis. 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 chronic lesions found in patients with a confirmed diagnosis of relapsing-remitting multiple sclerosis and compare it to the other assessments.

Eligible Conditions

  • Multiple Sclerosis
  • Multiple Sclerosis, Primary Progressive
  • Multiple Sclerosis Benign
  • Multiple Sclerosis, Acute Relapsing
  • Multiple Sclerosis, Chronic Progressive
  • Brain

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Multiple Sclerosis

Study Objectives

9 Primary · 42 Secondary · Reporting Duration: This will be assessed at the 6-month visit.

This will be assessed at the 3-month visit.
Informative Outcomes at 3 Months
This will be assessed at the 6-month visit.
Informative Outcomes at 6 Months
This will be assessed at the baseline and 3-month visits.
Change from Baseline in Clemastine Tolerability at 3 Months
Change from Baseline in Corpus Callosum Myelin Water Fraction at 3 Months
Change from Baseline in Corpus Callosum T1 Relaxation Time at 3 Months
Change from Baseline in Corpus Callosum UTE Fraction at 3 Months
Change from Baseline in Corticospinal T1 Relaxation Time at 3 Months
Change from Baseline in Corticospinal Tract Myelin Water Fraction at 3 Months
Change from Baseline in Corticospinal Tract UTE Fraction at 3 Months
Change from Baseline in LOI MWF at 3 Months
Change from Baseline in LOI T1 Relaxation Time at 3 Months
Change from Baseline in LOI UTE Fraction at 3 Months
Change from Baseline in Optic Radiation Myelin Water Fraction at 3 Months
Change from Baseline in Optic Radiation T1 Relaxation Time at 3 Months
Change from Baseline in Optic radiation UTE Fraction at 3 Months
Change from Baseline in Whole Brain MWF at 3 Months
Change from Baseline in Whole Brain T1 Relaxation Time at 3 Months
Change from Baseline in Whole Brain UTE Values at 3 Months
This will be assessed at the baseline and 6-month visits.
Change from Baseline in Clemastine Tolerability at 6 Months
Change from Baseline in Corpus Callosum Myelin Water Fraction at 6 Months
Change from Baseline in Corpus Callosum T1 Relaxation Time at 6 Months
Change from Baseline in Corpus Callosum UTE Fraction at 6 Months
Change from Baseline in Corticospinal Tract Myelin Water Fraction at 6 Months
Change from Baseline in Corticospinal Tract T1 Relaxation Time at 6 Months
Change from Baseline in Corticospinal Tract UTE Fraction at 6 Months
Change from Baseline in LOI MWF at 6 Months
Change from Baseline in LOI T1 Relaxation Time at 6 Months
Change from Baseline in LOI UTE Fraction at 6 Months
Change from Baseline in Optic Radiation Myelin Water Fraction at 6 Months
Change from Baseline in Optic Radiation T1 Relaxation Time at 6 Months
Change from Baseline in Optic radiation UTE Fraction at 6 Months
Change from Baseline in Whole Brain MWF at 6 Months
Change from Baseline in Whole Brain T1 Relaxation Time at 6 Months
Change from Baseline in Whole Brain UTE Values at 6 Months
This will be assessed at the baseline visit.
Clemastine Tolerability
Corpus Callosum Myelin Water Fraction
Corpus Callosum T1 Relaxation Time
Corpus Callosum UTE Fraction
Corticospinal Tract Myelin Water Fraction
Corticospinal Tract T1 Relaxation Time
Corticospinal Tract UTE Fraction
Informative Outcomes
LOI T1 Relaxation Time
LOI UTE Fraction
Lesion of interest (LOI) MWF
Optic Radiation Myelin Water Fraction
Optic Radiation T1 Relaxation time
Optic radiation UTE Fraction
Whole Brain MWF
Whole Brain T1 Relaxation Time
Whole Brain UTE Fraction

Trial Safety

Safety Progress

1 of 3

Other trials for Multiple Sclerosis

Trial Design

2 Treatment Groups

Clemastine 8 mg, then Placebo
1 of 2
Placebo, then Clemastine 8 mg
1 of 2
Experimental Treatment

74 Total Participants · 2 Treatment Groups

Primary Treatment: Clemastine Fumarate · Has Placebo Group · Phase 1 & 2

Clemastine 8 mg, then PlaceboExperimental Group · 2 Interventions: Placebo, Clemastine Fumarate · Intervention Types: Drug, Drug
Placebo, then Clemastine 8 mgExperimental Group · 2 Interventions: Placebo, Clemastine Fumarate · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: this will be assessed at the 6-month visit.
Closest Location: Sandler Neurosciences Building, Neurological Clinical Research Unit · San Francisco, CA
Photo of San Francisco 1Photo of San Francisco 2Photo of San Francisco 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Multiple Sclerosis
0 CompletedClinical Trials

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,246 Previous Clinical Trials
11,473,600 Total Patients Enrolled
17 Trials studying Multiple Sclerosis
2,022 Patients Enrolled for Multiple Sclerosis
United States Department of DefenseFED
759 Previous Clinical Trials
202,086 Total Patients Enrolled
9 Trials studying Multiple Sclerosis
630 Patients Enrolled for Multiple Sclerosis
Ari J Green, MD, MCRPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have obtained written informed consent prior to any assessment being performed.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References