A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Crossover Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of an Identified Small Molecule as a Remyelinating Agent in Multiple Sclerosis
This Phase II clinical trial will assess the efficacy, safety, and tolerability of an identified compound in the promotion of remyelination in patients with relapsing-remitting multiple sclerosis. This investigational drug was approved for the treatment of allergic rhinitis by the Food and Drug Administration (FDA) in past years. 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 multiple sclerosis.
Study participants will be asked to come to the UCSF MS Center at least 5 times over approximately 5-6 months. Participation will include an initial screening visit to determine eligibility, a baseline visit, and 3 follow-up visits (at 1, 3, and 5 months after the baseline 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 followed by 2 months of placebo while Group B will receive 3 months of placebo followed by 2 months of the active drug. 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.