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Clemastine Fumarate for Myelin Repair in MS

This study is testing if Clemastine Fumarate, a drug approved for allergies, can help repair myelin in people with Multiple Sclerosis (MS). Researchers want to see if this drug can help rebuild the protective coating around nerve fibers (myelin) that is damaged in MS. You might be able to join if you are 18-55 years old, have relapsing-remitting MS for less than 15 years, and meet other health requirements. The study will compare Clemastine Fumarate to a placebo (a sugar pill with no active drug). Success will be measured by changes in myelin levels in the brain using special MRI scans at 3 and 6 months. The current status of this study is unclear, but it plans to enroll 74 participants.

Study design
This is an interventional study comparing Clemastine Fumarate to a placebo. It plans to enroll 74 participants.
What's involved
You will have assessments at baseline, 3 months, and 6 months. These will include multi-parametric MRI scans.
Compensation
Not stated in the trial record.
Follow-up
Myelin levels will be assessed at 3 and 6 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05359653

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Recruiting
PHASE1Ages 18–55InterventionalTreatment
University of California, San Francisco
~74 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Clemastine FumaratePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Corpus Callosum Myelin Water Fraction
Measured over This will be assessed at the baseline visit.
+8 more outcomes measured

Conditions

Multiple Sclerosis (MS)
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Primary Progressive
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis Relapse
Multiple Sclerosis Brain Lesion
Multiple Sclerosis Benign

Explore related trials

Relapsing-Remitting Multiple Sclerosis

NCT05359653

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Sandler Neurosciences Building, Neurological Clinical Research Unit

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ari J Green, MD, MCR · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Harkeerat Halait, BS
[email protected]
415-745-1304
Email the study team

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Eligibility criteria

Inclusion

Written informed consent must be obtained prior to any assessment being performed.
Patients diagnosed with relapsing remitting multiple sclerosis and a disease duration of \< 15 years
Male or female patients aged 18-55 years (inclusive)
Use of appropriate contraception during period of trial (women). Before entry women must be:
Post-menopausal for at least 1 year OR
Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, male partner vasectomy or otherwise incapable of pregnancy) OR
Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study OR
Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) OR
Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject) Period abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) is not an acceptable method.

Exclusion

Radiologic identification of marked brain atrophy relative to patients age based on recent MRI and interpretation of expert neuroradiologist or PI
New lesion in most recent MRI (within 3 months)
Hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.
Treatment with corticosteroids within 30 days prior to screening.
Expanded Disability Status Scale (EDSS) ≥ 4.5
History of significant cardiac conduction block.
History of cancer.
Suicidal ideation or behavior in 6 months prior to baseline.
Pregnancy, breastfeeding or planning to become pregnant.
Involved with other study protocols simultaneously without prior approval.
Concomitant use of any other putative remyelinating therapy as determined by the investigator.
Prior treatment with total lymphoid irradiation, T cell or T cell receptor vaccination.
Prior treatment with alemtuzumab, mitoxantrone, or cyclophosphamide.
Serum creatinine \> 1.5 mg/dL; aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase \> 2 times the upper limit of normal. (Reported within 72 hours)
History of drug or alcohol abuse within the past year.
Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid \[MMA\] and homocysteine) or untreated hypothyroidism.
Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that in the PI's judgment may affect the interpretation of study results or patient safety.
History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study
Inability to participate in MRI, including extreme claustrophobia.
Any dental braces or permanent or undetachable metals in the jaw or face.

What this trial measures

  • Corpus Callosum Myelin Water FractionThis will be assessed at the baseline visit.

    The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum.

  • Change from Baseline in Corpus Callosum Myelin Water Fraction at 3 MonthsThis will be assessed at the baseline and 3-month visits.

    The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)

  • Change from Baseline in Corpus Callosum Myelin Water Fraction at 6 MonthsThis will be assessed at the baseline and 6-month visits.

    The efficacy of clemastine relative to placebo at increasing the myelin water fraction (MWF) (measured in %) from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)

  • Corpus Callosum T1 Relaxation TimeThis will be assessed at the baseline visit.

    The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI.

  • Change from Baseline in Corpus Callosum T1 Relaxation Time at 3 MonthsThis will be assessed at the baseline and 3-month visits.

    The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. Change = (3-month time - Baseline time)

  • Change from Baseline in Corpus Callosum T1 Relaxation Time at 6 MonthsThis will be assessed at the baseline and 6-month visits.

    The efficacy of clemastine relative to placebo at shortening the T1 relaxation time (measured in seconds) within the corpus callosum using T1 mapping protocols in an MRI. Change = (6-month time - Baseline time)

  • Corpus Callosum UTE FractionThis will be assessed at the baseline visit.

    The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum.

  • Change from Baseline in Corpus Callosum UTE Fraction at 3 MonthsThis will be assessed at the baseline and 3-month visits.

    The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (3-month % - Baseline %)

  • Change from Baseline in Corpus Callosum UTE Fraction at 6 MonthsThis will be assessed at the baseline and 6-month visits.

    The efficacy of clemastine relative to placebo at increasing the ultrashort echo time (UTE) fraction (measured in %) derived from magnetic resonance imaging of the corpus callosum. Change = (6-month % - Baseline %)