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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Jeffersi=on Moss Magee Rehabilitation
RECRUITING
Elkins Park
Contact Information
Primary
Kareema Murray
kareema.murray@jefferson.edu
215-663-6290
Time Frame
Start Date: 2026-07
Estimated Completion Date: 2027-08
Participants
Target number of participants: 42
Treatments
Experimental: Administration of BMS-986368
Drug: BMS-986368. Specified dose on specified days
Placebo_comparator: Placebo
Drug: Placebo Specified dose on specified days
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: Alberto Esquenazi

This content was sourced from clinicaltrials.gov