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A Study of BMS-986368 for Multiple Sclerosis Spasticity

This study is looking into a drug called BMS-986368 for people with spasticity (muscle stiffness and tightness) caused by multiple sclerosis (MS). Researchers want to see how well BMS-986368 works, if it's safe, and if people can tolerate it. You might receive BMS-986368 or a placebo (an inactive substance that looks like the study drug). To join, you must be 18 to 70 years old, have an MS diagnosis, and have had MS-related spasticity for at least six months. Your spasticity will be measured using a scale called the Modified Ashworth Scale. The study aims to enroll about 200 participants, but its current status is unclear.

Study design
This is an interventional study comparing BMS-986368 to a placebo, with a planned enrollment of 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at week 6, which gives an indication of the follow-up period for this specific measurement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06782490

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Celgene
~200 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:BMS-986368Placebo

At a glance

Recruiting sites
45 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score
Measured over At week 6

Conditions

Multiple Sclerosis Spasticity

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Multiple SclerosisSpasticity

Where it's being run

55 sites across 38 states
Ohio3
Victoria3
Ontario3
Germany3
Lesser Poland Voivodeship3
Poland3
Florida2
New South Wales2

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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 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.

What this trial measures

  • Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) scoreAt week 6