BMS-986368 for Post-Stroke Spasticity
(STIPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Who Is on the Research Team?
Alberto Esquenazi, MD
Principal Investigator
Thomas Jefferson University
Are You a Good Fit for This Trial?
This trial is for adults who had a stroke 4–18 months ago and have had muscle tightness (spasticity) in their arm for at least 2 months. They must meet certain movement and spasticity scores, not add new therapies during the study, and be able to read, speak, and understand English.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986368 or placebo with dose escalation from 1 mg to 6 mg once daily over 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Active Treatment Extension (DBATE)
Participants may opt into an additional 8-week period of active treatment with BMS-986368
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests BMS-986368—a drug that may help relax tight muscles—against a placebo in people with post-stroke spasticity. Participants are randomly assigned to receive either the drug or placebo to compare effects on muscle stiffness and safety.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Drug: BMS-986368. Specified dose on specified days
Drug: Placebo Specified dose on specified days
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alberto Esquenazi
Lead Sponsor
Bristol Meyer Squibb
Collaborator
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
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