Evaluating the Oral Drug BMS-986368 for Treating Muscle Spasticity After Stroke in Adults

What this Trial Is About

This research aims to evaluate the drug BMS-986368 for treating post-stroke spasticity in adults who have experienced a stroke. Post-stroke spasticity is a common complication that causes muscle tightness and spasms, impacting upper-limb function and quality of life. Current treatments may not fully control symptoms or have tolerability issues, so this study explores BMS-986368 as a potential new therapy based on early clinical and preclinical evidence. Participants will be randomly assigned to receive either BMS-986368 or a placebo during an 8-week double-blind treatment period. The drug dose will increase from 1 mg once daily to 3 mg and then 6 mg once daily. After this period, participants may join an optional 8-week extension where all receive the active drug, still under blinded conditions. The study includes a screening period lasting up to 4 weeks and a 4-week safety follow-up, making the total duration about 24 weeks. Throughout the study, participants will undergo assessments such as the Tardieu Scale and Upper Limb Fugl-Meyer Assessment to measure spasticity and motor function at weeks 8 and 16. Additional evaluations include safety monitoring through adverse event tracking, questionnaires on mood, and blood tests for drug levels. Researchers will closely monitor tolerability and safety during and after treatment to understand the effects of BMS-986368 in adults with post-stroke spasticity.

A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)