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Administration of BMS-986368

Phase 2

Post-Stroke Spasticity | Small molecule | Neurology |Bristol-Myers Squibb Company|Trials Updated: Oct 1, 2026

Administration of BMS-986368 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Administration of BMS-986368 clinical trials

Administration of BMS-986368 · 1 trial · 1 indication

Phase 2 1
NCT07704840A 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)Post-Stroke Spasticity
RECRUITING42 Analytics
PHASE2RECRUITING
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)
Post-Stroke Spasticity
NCT0770484042
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Study Endpoints

Primary Endpoints

Tardieu Scale
At 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) Scale
At 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.

Secondary Endpoints

Tardieu Scale - DBATE
At week 16
Upper Limb Fugl-Meyer Assessment (FMA-UE) Scale- DBATE
At week 16
Total Numeric-transformed Modified Ashworth Scale (TNmAS)
At week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension phase
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Administration of BMS-986368EXPERIMENTALDrug: BMS-986368. Specified dose on specified days
PlaceboPLACEBO_COMPARATORDrug: Placebo Specified dose on specified days

Interventions

NameTypeDescription
Administration of BMS-986368DRUGAdministration of BMS-986368. Specified dose on specified days
PlaceboDRUGInterventions: Drug: Placebo
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

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. ...

Countries:United States
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