Phase 2 Study of Oral BMS-986368 for Treating Spasticity in Adults With Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the efficacy, safety, and tolerability of BMS-986368 in adults with Multiple Sclerosis Spasticity. This Phase 2 randomized, double-blind, placebo-controlled study aims to assess three different doses of this oral FAAHMAGL inhibitor to better understand its impact on spasticity symptoms in participants diagnosed with MS who have experienced spasticity for at least six months. Participants will be randomly assigned to one of four groups receiving either one of three doses of BMS-986368 or a placebo. The medication is administered orally on specified days during the study period. The trial includes a treatment phase lasting six weeks, followed by safety monitoring up to 16 weeks to evaluate adverse events and treatment tolerability. During the study, participants will undergo assessments including the Total Numeric-transformed Modified Ashworth Scale for the most affected lower limb, Numeric Rating Scale for Spasticity, MS Spasticity Scale, Timed 25-Foot Walk, and Clinical Global Impression of Severity. Researchers will monitor plasma drug levels and adverse events, including suicidal ideation and withdrawal symptoms, throughout the trial. The study duration and follow-up span up to 16 weeks from treatment start.

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity