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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)

ConditionPost-Stroke Spasticity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAlberto Esquenazi

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Administration of BMS-986368

    Drug

    Administration of BMS-986368. Specified dose on specified days

  • Placebo

    Drug

    Interventions: Drug: Placebo

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Administration of BMS-986368Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tardieu Scale

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

Time frame
At Week 8
2

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.

Time frame
At Week 8

Secondary outcomes

1

Tardieu Scale - DBATE

Change from baseline in in elbow and wrist Tardieu Scale for participants in the Optional Active Treatment Extension Phase (DBATE).

Time frame
At week 16
2

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

Change from baseline iat Week 16 for patients in the for patients in the Optional Active Treatment Extension Phase (DBATE)

Time frame
At week 16
3

Total Numeric-transformed Modified Ashworth Scale (TNmAS)

Change from baseline in Total Numeric-transformed Modified Ashworth Scale; Clinician-rated measure of muscle tone/spasticity.

Time frame
At week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension phase
4

Numeric Rating Scale - Spasticity (NRS-S)

Change from baseline. Participant-rated severity of spasticity on a 0-10 scale

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alberto Esquenazi

Lead sponsor

Thomas Jefferson University

Sponsor institution

Bristol-Myers Squibb

Collaborator

Source ClinicalTrials.gov
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