Recruiting
Phase 2

BMS-986368

Sponsor:

Alberto Esquenazi

Code:

NCT07704840

Conditions

Post-Stroke Spasticity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Administration of BMS-986368

Placebo

Study Details

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

Study ID

NCT07704840

Start date

Sep 2, 2026

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Administration of BMS-986368

Drug: BMS-986368. Specified dose on specified days

placebo comparator: Placebo

Drug: Placebo Specified dose on specified days

Interventions

Administration of BMS-986368

Administration of BMS-986368. Specified dose on specified days

Placebo

Interventions:

Drug: Placebo

Primary outcome measure

  • Tardieu Scale [ Time Frame: At Week 8 ]
  • Upper Limb Fugl-Meyer Assessment (FMA-UE) Scale [ Time Frame: At Week 8 ]

Central Contacts and Locations

Central contacts

Kareema Murray

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

Locations

Jeffersi=on Moss Magee Rehabilitation

Recruiting

Elkins Park, Pennsylvania, United States, 19027

Contacts

Kareema Murray

215-663-6290Kareema.Murray@jefferson.edu

Principal Investigator:

Alberto Esquenazi, MD

More Information

Sponsor

Alberto Esquenazi

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • Stroke
  • Spasticity
  • Neurological Disorders
  • Upper Limb Spasticity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Alberto Esquenazi on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.