Assessing the effects of Clemastine Fumarate on myelin repair in MS patients

A Randomized, Double-Blind, Delayed Treatment, Placebo-Controlled Trial to Assess the Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

This study is testing if a medication called Clemastine Fumarate can help repair the protective covering of nerves in people with relapsing-remitting multiple sclerosis.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Drugs / interventions: alemtuzumab, cyclophosphamide
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT05359653 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of Clemastine Fumarate as a potential therapy for myelin repair in patients with multiple sclerosis (MS). It utilizes multi-parametric MRI assessments to measure changes in myelin integrity and function. The study includes patients diagnosed with relapsing-remitting MS and aims to determine if Clemastine can promote remyelination, addressing a significant unmet need in MS treatment. The trial is conducted at the University of California, San Francisco, leveraging prior findings that suggest Clemastine may enhance the differentiation of oligodendrocyte precursor cells into myelinating oligodendrocytes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-55 with a diagnosis of relapsing-remitting multiple sclerosis and a disease duration of less than 15 years.

Not a fit: Patients with primary progressive or chronic progressive forms of multiple sclerosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel approach to repairing myelin damage in MS patients, potentially improving neurological function and quality of life.

How similar studies have performed: Previous studies have shown promising results for similar remyelinating agents, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

San Francisco, California

• Sandler Neurosciences Building, Neurological Clinical Research Unit — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Ari J Green, MD, MCR — University of California, San Francisco
• Study coordinator: Harkeerat Halait, BS

Conditions Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Primary Progressive; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis Relapse; Multiple Sclerosis Brain Lesion; Multiple Sclerosis Benign; multiple sclerosis