NCT07704840RecruitingPhase 2
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)
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 10 Jul 2026
- Start date
- 2 Sept 2026
- Primary completion date
- Jun 2027
- Lead sponsor
- Alberto Esquenazi
- Diseases
- Stroke
- NCT number
- NCT07704840
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 2 Sept 2026 to the primary completion date, Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 illness
- 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.
Other
- Individuals who are pregnant or breastfeeding.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jeffersi=on Moss Magee Rehabilitation Coordinator of this site? Confirm its status | Elkins Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.