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)

NCT07704840 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: iRISID-2026-0193IM045-1032
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Post-Stroke Spasticity

Keywords

Stroke; Spasticity; Neurological Disorders; Upper Limb Spasticity

Outcome Measures

Primary Outcomes (2)

• Tardieu Scale

  Change from baseline in elbow and wrist Tardieu Scale. Clinical assessment with higher scores indicating greater spasticity.

  At Week 8

• Upper Limb Fugl-Meyer Assessment (FMA-UE) Scale

  Change from baseline, Clinical Assessment of upper-extremity motor function and sensorimotor recovery after stroke. Scores range from 0 to 66, with higher scores indicating better motor function.

  At Week 8

Secondary Outcomes (14)

• Tardieu Scale - DBATE

  At week 16

• Upper Limb Fugl-Meyer Assessment (FMA-UE) Scale- DBATE

  At week 16

• Total Numeric-transformed Modified Ashworth Scale (TNmAS)

  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)

  At Week 8 for all participants. At Week 16 for participants in the Optional Active Treatment Extension Phase

• Patient Health Questionnaire-9 (PHQ-9)

  At Week 8 for all participants Additionally at Week 16 for participants in the Optional Active Treatment Extension Phase

Study Arms (2)

Administration of BMS-986368

EXPERIMENTAL

Drug: BMS-986368. Specified dose on specified days

Drug: Administration of BMS-986368

Placebo

PLACEBO COMPARATOR

Drug: Placebo Specified dose on specified days

Drug: Placebo

Interventions

Administration of BMS-986368 DRUG

Administration of BMS-986368. Specified dose on specified days

Administration of BMS-986368

Placebo DRUG

Interventions: Drug: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alberto Esquenazi: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Jeffersi=on Moss Magee Rehabilitation

Elkins Park, Pennsylvania, 19027, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Esquenazi, MD

  Thomas Jefferson University

  STUDY DIRECTOR

Central Study Contacts

Kareema Murray

CONTACT

215-663-6290; kareema.murray@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Clinical Officer Jefferson Moss-Magee Rehabilitation

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

US (1)