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The STIPS Study: BMS-986368 for Post-Stroke Spasticity

This study is testing a drug called BMS-986368 to see if it can help adults who have muscle stiffness and spasms (spasticity) after a stroke. BMS-986368 is designed to increase natural body compounds that may calm nerves causing tight muscles. The study will also look at how safe BMS-986368 is. You might be able to join if you are 18 to 80 years old, had a stroke 4 to 18 months ago, and have had post-stroke spasticity for at least two months. The researchers will measure changes in your muscle stiffness using scales like the Tardieu Scale and the Upper Limb Fugl-Meyer Assessment (FMA-UE) after 8 weeks to see if the drug is working. The current recruitment status is unclear.

Study design
This is a pilot study, meaning it's an early look at the drug. It's a randomized, double-blind, placebo-controlled trial, which means some participants will receive the drug and others a placebo, and neither you nor your doctor will know which you are receiving. It plans to enroll 42 participants.
What's involved
You would have a screening period of up to 4 weeks, followed by an 8-week treatment period. There's an optional 8-week extension and a 4-week safety follow-up, making the maximum study duration about 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a 4-week safety follow-up period after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07704840

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)

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Alberto Esquenazi
~42 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Administration of BMS-986368Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tardieu Scale
Measured over At Week 8
+1 more outcome measured

Conditions

Post-Stroke Spasticity

Explore related trials

Post-Stroke SpasticityStroke

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Alberto Esquenazi, MD · STUDY_DIRECTOR · Thomas Jefferson University

Who to contact

Kareema Murray
[email protected]
215-663-6290
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Tardieu ScaleAt Week 8

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

  • Upper Limb Fugl-Meyer Assessment (FMA-UE) ScaleAt Week 8

    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.