NCT07704840 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)
| NCT ID | NCT07704840 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alberto Esquenazi |
| Condition | Post-Stroke Spasticity |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-09-02 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2026-09-02 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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.
Contact & Investigator
Alberto Esquenazi, MD
STUDY DIRECTOR
Thomas Jefferson University
Frequently Asked Questions
Who can join the NCT07704840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Post-Stroke Spasticity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07704840 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07704840 currently recruiting?
Yes, NCT07704840 is actively recruiting participants. Contact the research team at kareema.murray@jefferson.edu for enrollment information.
Where is the NCT07704840 trial being conducted?
This trial is being conducted at Elkins Park, United States.
Who is sponsoring the NCT07704840 clinical trial?
NCT07704840 is sponsored by Alberto Esquenazi. The principal investigator is Alberto Esquenazi, MD at Thomas Jefferson University. The trial plans to enroll 42 participants.
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