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A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
NCT06782490 · Celgene
In plain English
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Official title
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)
About this study
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
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.
Study design
Enrollment target: 200 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-06-05
Estimated completion: 2027-06-09
Last updated: 2026-03-25
Interventions
Drug: BMS-986368Drug: Placebo
Primary outcomes
- • Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score (At week 6)
Sponsor
Celgene · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (53)
Local Institution - 0033Not Yet Recruiting
Birmingham, Alabama, United States
Perseverance Research Center,LLCRecruiting
Scottsdale, Arizona, United States
Local Institution - 0017Withdrawn
Aurora, Colorado, United States
Aqualane Clinical ResearchRecruiting
Naples, Florida, United States
USF HealthRecruiting
Tampa, Florida, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Neurology Center of New EnglandRecruiting
Foxborough, Massachusetts, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
University of Cincinnati Medical CenterRecruiting
Cincinnati, Ohio, United States
Local Institution - 0039Not Yet Recruiting
Columbus, Ohio, United States
Local Institution - 0069Withdrawn
Columbus, Ohio, United States
Local Institution - 0067Not Yet Recruiting
Philadelphia, Pennsylvania, United States
Hope NeurologyRecruiting
Knoxville, Tennessee, United States
EvergreenHealth Medical CenterRecruiting
Kirkland, Washington, United States
John Hunter HospitalRecruiting
Newcastle, New South Wales, Australia
University of Sydney - Brain and Mind Research Institute (BMRI)Recruiting
Sydney, New South Wales, Australia
Centre for Neuroscience InnovationRecruiting
Kent Town, South Australia, Australia
Box Hill HospitalRecruiting
Box Hill, Victoria, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
The Royal Melbourne HospitalRecruiting
Parkville, Victoria, Australia
Perron InstituteRecruiting
Nedlands, Western Australia, Australia
University Of Alberta HospitalRecruiting
Edmonton, Alberta, Canada
University Hospital - London Health Sciences CentreRecruiting
London, Ontario, Canada
The Ottawa Hospital - General CampusRecruiting
Ottawa, Ontario, Canada
Local Institution - 0028Not Yet Recruiting
Toronto, Ontario, Canada
Centre de Recherche Saint-LouisRecruiting
Lévis, Quebec, Canada
Montreal Neurological Institute and HospitalRecruiting
Montreal, Quebec, Canada
Fakultni Nemocnice u sv. Anny v BrneRecruiting
Brno, Brno-město, Czechia
Local Institution - 0010Not Yet Recruiting
Hradec Králové, Hradec Králové, Czechia
Vseobecna fakultni nemocnice v PrazeRecruiting
Prague, Praha 2, Czechia
Fakultni Thomayerova nemocniceRecruiting
Prague, Praha 4, Czechia
Local Institution - 0011Withdrawn
Prague, Praha 5, Czechia
Nemocnice Pardubického krajeRecruiting
Pardubice, Czechia
Nemocnice TepliceRecruiting
Teplice, Ústí nad Labem Region, Czechia
Klinikum Würzburg MitteRecruiting
Würzburg, Bavaria, Germany
Neurologischen Gemeinschaftspraxis Kassel und VellmarRecruiting
Kassel, Hesse, Germany
St. Josef und St. Elisabeth Hospital gGmbHRecruiting
Bochum, North Rhine-Westphalia, Germany
Local Institution - 0060Not Yet Recruiting
Münster, North Rhine-Westphalia, Germany
Local Institution - 0031Withdrawn
Meisenheim, Rhineland-Palatinate, Germany
Universitätsklinikum JenaRecruiting
Jena, Thuringia, Germany
Neurozentrum BielefeldRecruiting
Bielefeld, Germany
Universitaetsklinikum Carl Gustav Carus DresdenRecruiting
Dresden, Germany
Local Institution - 0020Withdrawn
Essen, Germany
Centrum Medyczne NEUROMEDRecruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0044Not Yet Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Pratia MCM KrakowRecruiting
Krakow, Lesser Poland Voivodeship, Poland
SP ZOZ Szpital Uniwersytecki w KrakowieRecruiting
Krakow, Lesser Poland Voivodeship, Poland
Instytut Zdrowia Dr Boczarska JedynakRecruiting
Oświęcim, Lesser Poland Voivodeship, Poland
Centrum Medyczne NeuroProtectRecruiting
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0061Withdrawn
Gdansk, Poland
M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SMRecruiting
Katowice, Poland
Local Institution - 0051Withdrawn
Słomniki, Poland
Puerto Rico Multiple Sclerosis CenterRecruiting
Caguas, Puerto Rico