BMS-986368 to reduce spasticity in people with MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Alabama Neurology Associates
  Birmingham, Alabama, United States Recruiting
• Perseverance Research Center,LLC
  Scottsdale, Arizona, United States Recruiting
• Aqualane Clinical Research
  Naples, Florida, United States Recruiting
• USF Health
  Tampa, Florida, United States Recruiting
• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting
• Neurology Center of New England
  Foxborough, Massachusetts, United States Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.