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BMS-986368 to reduce spasticity in people with MS

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)

Phase 2 Interventional Celgene · NCT06782490

This will test whether BMS-986368 reduces spasticity in adults with multiple sclerosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorCelgene Industry-sponsored
Locations54 sites (Birmingham, Alabama and 53 other locations)
Trial IDNCT06782490 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, placebo-controlled interventional trial testing BMS-986368 for MS-related spasticity. Eligible participants have had spasticity for at least six months, a Modified Ashworth Scale score of ≥2 in two muscle groups (including at least one leg group), and an EDSS of 3.0–6.5. Participants are assigned to receive BMS-986368 or placebo and are monitored for changes in spasticity as well as safety and tolerability. The trial is being conducted at multiple U.S. sites.

Who should consider this trial

Good fit: Adults with MS who have had spasticity for at least six months, an mAS score ≥2 in two muscle groups (including at least one leg group), and EDSS between 3.0 and 6.5.

Not a fit: People without MS-related spasticity, those with a recent MS relapse or other conditions that cause spasticity, or those with disqualifying substance abuse history are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, BMS-986368 could provide a new option to reduce spasticity and improve daily function for people with MS.

How similar studies have performed: Some approved drugs (for example, baclofen and tizanidine) reduce MS spasticity, but BMS-986368 is a newer agent with limited published data in this indication.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Sclerosis SpasticitySpasticityMultiple SclerosisBMS-986368
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.