The goal of this clinical trial is to learn if the drug BMS-986368 works to treat post stroke spasticity in adults who have had a stroke. BMS-986368 is a designed to increase natural compounds in the body that may help calm nerves that cause muscles to be tight or spasm. The study will also learn about the safety of drug BMS-986368
Ischemic or hemorrhagic stroke diagnosis 4 to 18 months prior to enrollment.
History of post stroke spasticity for at least 2 months prior to Screening Visit.
Modified Ashworth Scale (mAS) score ≥2 and <4 for affected elbow and wrist joints at Screen and Baseline Visits.
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) greater than 22 at Screen and Baseline Visits
Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity.
Participants must not have a history of any substance abuse disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic Criteria for Drug and Alcohol Abuse.
Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out prior to randomization.
Participants must not have used FAAH/MAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to randomization.
Alberto Esquenazi
Lead sponsor
Thomas Jefferson University
Sponsor institution
Bristol-Myers Squibb
Collaborator