Evaluating Clemastine Fumarate for Myelin Repair in Relapsing-Remitting Multiple Sclerosis Using Advanced MRI

What this Trial Is About

Researchers are studying the effects of Clemastine Fumarate as a potential myelin repair treatment for patients with relapsing-remitting multiple sclerosis who have chronic nerve damage caused by demyelination. This study aims to evaluate changes in brain lesions using advanced MRI techniques, including a new Ultrashort Echo Time UTE MRI, to better understand the drugs protective and repair effects. The trial follows up on previous research that showed encouraging results for Clemastine in repairing nerve damage in MS. Participants will be randomly assigned to one of two groups in a crossover design. One group will take Clemastine 8 mg daily for 90 days followed by a placebo for 90 days, while the other group will receive placebo first then Clemastine. The study will use multiple MRI sequences focusing on the corpus callosum and other brain regions to measure myelin water fraction, T1 relaxation time, and UTE fraction at baseline, 3 months, and 6 months. During the study, participants will undergo MRI scans and clinical assessments at the start, midpoint, and end of treatment periods to track changes in myelin and brain lesions. Researchers will also monitor tolerability and any adverse effects. The trial includes detailed measurement of MRI changes in brain areas affected by MS and aims to improve understanding of remyelination therapies. Participation lasts about 6 months with scheduled visits for imaging and clinical evaluation.

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