A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis
This Phase II clinical trial will assess the efficacy, safety, and tolerability of an identified compound in the promotion of remyelination in patients experiencing acute optic neuritis. This investigational drug was approved for the treatment of allergic rhinitis by the Food and Drug Administration (FDA) in 1977. Since then, the medication has been identified at UCSF as a compound that potentially enhances oligodendrocyte differentiation and remyelination. However, it is not approved as a therapy for optic neuritis.
Study participants will be asked to come to the UCSF Multiple Sclerosis Center at least 5 times over approximately 9 months. Participation will include an initial screening visit to determine eligibility, and 4 follow-up visits (at 1 week, 1 month, 3 months, and 9 months after the screening visit). All study visits will occur at the UCSF campus. Most visits will take about 3 hours.
Study participation will involve taking the study drug by mouth, twice each day, or the equivalent amount of placebo. Participants will be randomized into one of two groups: Group A and Group B. Group A will receive 3 months of active drug Group B will receive 3 months of placebo. Both groups will end therapy/placebo at 3 months, and will be evaluated again at the 9 month visit. Patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot participate in any other investigational new drug research study for which drug effects on remyelination are unknown.