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A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity

RecruitingPhase 2

A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1)

Who can join

Ages 18 to 70 · All sexes

Full eligibility criteria
Inclusion Criteria

* Participants must have a multiple sclerosis (MS) diagnosis.
* Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1.
* Participants must have a Modified Ashworth Scale (mAS) score ≥2 in each of 2 muscle groups (at least one muscle group in the leg, excluding ankle plantar flexors) at Visit 1.
* Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 at Visit 1.

Exclusion Criteria

* 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 an acute MS exacerbation/relapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2.
* 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 by Visit 2.
* 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 Visit 1.
* Other protocol-defined Inclusion/Exclusion criteria apply.

About the study

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity

What is being tested

Sponsor: Celgene · Participants: 200 · Started: Jun 5, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06782490

Locations in the U.S.

AlabamaAlabama Neurology Associates, Birmingham
ArizonaPerseverance Research Center,LLC, Scottsdale
FloridaAqualane Clinical Research, Naples
USF Health, Tampa
KansasUniversity of Kansas Medical Center, Kansas City
MassachusettsNeurology Center of New England, Foxborough
MichiganNorthwest Neurology, Southfield
MissouriWashington University School of Medicine, St Louis
OhioUniversity of Cincinnati Medical Center, Cincinnati
Riverside Methodist Hospital, Columbus
PennsylvaniaThomas Jefferson University, Jefferson Headache Center, Philadelphia
TennesseeHope Neurology, Knoxville
TexasLocal Institution - 0072, Lewisville (Not yet recruiting)
WashingtonEvergreenHealth Medical Center, Kirkland

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.