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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis Spasticity

In brief

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

Key facts

Study ID

NCT06782490

Run by

Celgene

People needed

200

Starts

2025-06-05

Expected to finish

2027-06-09

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Unity Health Toronto, St. Michael's Hospital — Toronto, Ontario, Canada (enrolling)
• Montreal Neurological Institute and Hospital — Montreal, Quebec, Canada (enrolling)
• Perseverance Research Center,LLC — Scottsdale, Arizona, United States (enrolling)
• USF Health — Tampa, Florida, United States (enrolling)
• Centre de Recherche Saint-Louis — Lévis, Quebec, Canada (enrolling)
• Neurology Center of New England — Foxborough, Massachusetts, United States (enrolling)
• Aqualane Clinical Research — Naples, Florida, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Riverside Methodist Hospital — Columbus, Ohio, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Alabama Neurology Associates — Birmingham, Alabama, United States (enrolling)
• Hope Neurology — Knoxville, Tennessee, United States (enrolling)
• EvergreenHealth Medical Center — Kirkland, Washington, United States (enrolling)
• John Hunter Hospital — Newcastle, New South Wales, Australia (enrolling)
• University of Sydney - Brain and Mind Research Institute (BMRI) — Sydney, New South Wales, Australia (enrolling)
• Centre for Neuroscience Innovation — Kent Town, South Australia, Australia (enrolling)
• Box Hill Hospital — Box Hill, Victoria, Australia (enrolling)
• Austin Health — Heidelberg, Victoria, Australia (enrolling)
• The Royal Melbourne Hospital — Parkville, Victoria, Australia (enrolling)
• Perron Institute — Nedlands, Western Australia, Australia (enrolling)
• University Of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
• University Hospital - London Health Sciences Centre — London, Ontario, Canada (enrolling)
• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada (enrolling)
• Fakultni Nemocnice u sv. Anny v Brne — Brno, Brno-město, Czechia (enrolling)

Full record on ClinicalTrials.gov

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