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New treatment option for Multiple Sclerosis (MS)
Official title Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy
ClinicalTrials.gov ID: NCT05359653
What this study is testing
What is Clemastine Fumarate?
Clemastine Fumarate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for multiple sclerosis (ms).
Also referred to as Clemastine, Dayhist.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.