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)

Post-stroke spasticity (PSS) is a common and disabling complication of stroke that can impair upper-limb function, limit activities of daily living, and negatively affect quality of life. Current treatment options, including oral antispasticity medications and botulinum toxin injections, may provide incomplete symptom control and are often associated with tolerability limitations. Therefore, there is a need for novel therapies that can improve both spasticity and functional recovery in individuals with PSS. Preclinical evidence and early clinical experience support evaluation of BMS-986368 as a treatment for post-stroke spasticity. The STIPS Study is a Phase 2, randomized, double-blind, placebo-controlled pilot trial designed to evaluate the efficacy, safety, and tolerability of BMS-986368 in adults with post-stroke spasticity. The study consists of:

* A screening period of up to 4 weeks * An 8-week double-blind treatment period * An optional 8-week double-blind active treatment extension (DBATE) * A 4-week safety follow-up period The maximum study duration is approximately 24 weeks. During the double-blind treatment period, participants randomized to active treatment will receive oral BMS-986368 with dose escalation from 1 mg once daily, to 3 mg once daily and then 6 mg once daily. Participants randomized to placebo will receive matching placebo capsules. Participants who complete the double-blind treatment period may elect to enter the DBATE, during which all participants receive active treatment while maintaining study blinding. The study hypothesis is that BMS-986368 administered up to 6 mg once daily will result in greater improvement in spasticity and upper-extremity motor function compared with placebo, while demonstrating an acceptable safety and tolerability profile in participants with post-stroke spasticity

• Tardieu Scale - DBATE [Срок оценки: At week 16]
• Upper Limb Fugl-Meyer Assessment (FMA-UE) Scale- DBATE [Срок оценки: At week 16]
• Total Numeric-transformed Modified Ashworth Scale (TNmAS) [Срок оценки: At week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension phase]
• Numeric Rating Scale - Spasticity (NRS-S) [Срок оценки: At Week 8 for all participants. At Week 16 for participants in the Optional Active Treatment Extension Phase]
• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: At Week 8 for all participants Additionally at Week 16 for participants in the Optional Active Treatment Extension Phase]
• Clinical Global Impression of Severity (CGI-S) [Срок оценки: At Week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension Phase]
• Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to week 16]]
• Serious adverse events (SAEs) [Срок оценки: Up to week 16]
• Adverse events (AEs) leading to treatment discontinuation [Срок оценки: Up to week 16]]
• AEs leading to death [Срок оценки: Up to week 16]]
• AEs leading to clinically significant lab abnormalities [Срок оценки: [Time Frame: Up to week 16]]
• Suicidal Ideation and Behavior [Срок оценки: Up to week 16]]