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)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Post-Stroke Spasticity
In brief
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
Key facts
- Study ID
- NCT07704840
- Run by
- Alberto Esquenazi
- People needed
- 42
- Starts
- 2026-07-01
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Willing to participate with no therapy additions during study duration.
- Participant must be able to read, speak, and understand English usage
You may not qualify if…
- Individuals who are pregnant or breastfeeding.
- 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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where it is running
- Jeffersi=on Moss Magee Rehabilitation — Elkins Park, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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