Tests BMS-986368 pill for muscle stiffness in multiple sclerosis
Tests a pill, BMS-986368, against placebo for muscle stiffness in adults with multiple sclerosis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Key facts
- Where
- Caguas, Puerto RicoSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06782490, who can take part
Where in Puerto Rico
- Puerto Rico Multiple Sclerosis CenterCaguas, Puerto RicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celgene
- Trial code
- NCT06782490
- Record updated
- 27 October 2026
- Original description
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis SpasticityRead full original descriptionShow less
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)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
Inclusion: 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: 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 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; 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; Other protocol-defined Inclusion/Exclusion criteria apply.