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

NCT06782490

RecruitingPhase 2

Sponsor: Celgene

Conditions: Multiple Sclerosis Spasticity

Interventions: BMS-986368, Placebo

Countries: United States, Australia, Canada, Czechia, Germany, Poland, Puerto Rico

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (55)

Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Aurora, Colorado, United States
Naples, Florida, United States
Tampa, Florida, United States
Kansas City, Kansas, United States
Foxborough, Massachusetts, United States
Southfield, Michigan, United States
St Louis, Missouri, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Lewisville, Texas, United States
Kirkland, Washington, United States
Newcastle, New South Wales, Australia
Sydney, New South Wales, Australia
Kent Town, South Australia, Australia
Box Hill, Victoria, Australia
Heidelberg, Victoria, Australia
Parkville, Victoria, Australia
Nedlands, Western Australia, Australia
Edmonton, Alberta, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Lévis, Quebec, Canada
Montreal, Quebec, Canada
Brno, Brno-město, Czechia
+ 25 more on CT.gov