BMS-986368 for post-stroke spasticity in adults
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Pilot Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Post-stroke Spasticity
Run by Thomas Jefferson University · NCT07704840 · Data updated 2026-11-12
This trial tests whether the drug BMS-986368 can help reduce spasticity after stroke in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Elkins Park, Pennsylvania) |
| Status | Recruiting |
| Started | September 2, 2026 |
| Main results expected | June 2027 |
| Study ends | August 2027 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07704840 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with ischemic or hemorrhagic stroke 4–18 months prior, with persistent post-stroke spasticity and specific motor-scale criteria.
✕Probably not a fit
Patients who do not respond to the drug or who meet safety exclusions may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2, randomized, double-blind, placebo-controlled study evaluates the safety, tolerability, and potential efficacy of BMS-986368 in adults with post-stroke spasticity. Participants may receive escalating oral doses of the drug or placebo over an 8-week treatment period, with an optional 8-week active-treatment extension and a 4-week safety follow-up, for up to about 24 weeks total. The study includes screening, treatment, and follow-up visits to monitor motor symptoms and safety. Primary focus is on reduction of muscle tightness and improvement in upper-extremity function, alongside safety data collection.
Why it matters
Potential benefit: If successful, participants could experience reduced muscle spasticity and improved ability to use the affected arm.
How similar studies have gone: Prior preclinical and early clinical data support exploring FAAH/MAGL inhibition for spasticity, but this exact approach in post-stroke spasticity is still being investigated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: 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's running
-
Jeffersi=on Moss Magee Rehabilitation
Elkins Park, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Kareema Murray
- Email: kareema.murray@jefferson.edu
- Phone: 215-663-6290
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.