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A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Sponsor: Celgene
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
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)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-06-05
Completion Date
2027-06-09
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
BMS-986368
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (53)
Local Institution - 0033
Birmingham, Alabama, United States
Perseverance Research Center,LLC
Scottsdale, Arizona, United States
Local Institution - 0017
Aurora, Colorado, United States
Aqualane Clinical Research
Naples, Florida, United States
USF Health
Tampa, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Neurology Center of New England
Foxborough, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Local Institution - 0039
Columbus, Ohio, United States
Local Institution - 0069
Columbus, Ohio, United States
Local Institution - 0067
Philadelphia, Pennsylvania, United States
Hope Neurology
Knoxville, Tennessee, United States
EvergreenHealth Medical Center
Kirkland, Washington, United States
John Hunter Hospital
Newcastle, New South Wales, Australia
University of Sydney - Brain and Mind Research Institute (BMRI)
Sydney, New South Wales, Australia
Centre for Neuroscience Innovation
Kent Town, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Perron Institute
Nedlands, Western Australia, Australia
University Of Alberta Hospital
Edmonton, Alberta, Canada
University Hospital - London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Local Institution - 0028
Toronto, Ontario, Canada
Centre de Recherche Saint-Louis
Lévis, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Fakultni Nemocnice u sv. Anny v Brne
Brno, Brno-město, Czechia
Local Institution - 0010
Hradec Králové, Hradec Králové, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Praha 2, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, Czechia
Local Institution - 0011
Prague, Praha 5, Czechia
Nemocnice Pardubického kraje
Pardubice, Czechia
Nemocnice Teplice
Teplice, Ústecký kraj, Czechia
Klinikum Würzburg Mitte
Würzburg, Bavaria, Germany
Neurologischen Gemeinschaftspraxis Kassel und Vellmar
Kassel, Hesse, Germany
St. Josef und St. Elisabeth Hospital gGmbH
Bochum, North Rhine-Westphalia, Germany
Local Institution - 0060
Münster, North Rhine-Westphalia, Germany
Local Institution - 0031
Meisenheim, Rhineland-Palatinate, Germany
Universitätsklinikum Jena
Jena, Thuringia, Germany
Neurozentrum Bielefeld
Bielefeld, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Local Institution - 0020
Essen, Germany
Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0044
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship, Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim, Lesser Poland Voivodeship, Poland
Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0061
Gdansk, Poland
M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM
Katowice, Poland
Local Institution - 0051
Słomniki, Poland
Puerto Rico Multiple Sclerosis Center
Caguas, Puerto Rico