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)
Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Alabama Neurology Associates
RECRUITING
Birmingham
Arizona
Perseverance Research Center,LLC
RECRUITING
Scottsdale
Colorado
Local Institution - 0017
WITHDRAWN
Aurora
Florida
Aqualane Clinical Research
RECRUITING
Naples
USF Health
RECRUITING
Tampa
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Neurology Center of New England
RECRUITING
Foxborough
Michigan
Local Institution - 0071
NOT_YET_RECRUITING
Southfield
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Local Institution - 0069
WITHDRAWN
Columbus
Riverside Methodist Hospital
RECRUITING
Columbus
Pennsylvania
Local Institution - 0067
NOT_YET_RECRUITING
Philadelphia
Tennessee
Hope Neurology
RECRUITING
Knoxville
Washington
EvergreenHealth Medical Center
RECRUITING
Kirkland
Other Locations
Australia
Box Hill Hospital
RECRUITING
Box Hill
Austin Health
RECRUITING
Heidelberg
Centre for Neuroscience Innovation
RECRUITING
Kent Town
Perron Institute
RECRUITING
Nedlands
John Hunter Hospital
RECRUITING
Newcastle
The Royal Melbourne Hospital
RECRUITING
Parkville
University of Sydney - Brain and Mind Research Institute (BMRI)
RECRUITING
Sydney
Canada
University Of Alberta Hospital
RECRUITING
Edmonton
Centre de Recherche Saint-Louis
RECRUITING
Lévis
University Hospital - London Health Sciences Centre
RECRUITING
London
Montreal Neurological Institute and Hospital
RECRUITING
Montreal
The Ottawa Hospital - General Campus
RECRUITING
Ottawa
Unity Health Toronto, St. Michael's Hospital
RECRUITING
Toronto
Germany
Neurozentrum Bielefeld
RECRUITING
Bielefeld
St. Josef und St. Elisabeth Hospital gGmbH
RECRUITING
Bochum
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Local Institution - 0020
WITHDRAWN
Essen
Universitätsklinikum Jena
RECRUITING
Jena
Neurologischen Gemeinschaftspraxis Kassel und Vellmar
RECRUITING
Kassel
Local Institution - 0031
WITHDRAWN
Meisenheim
Universitätsklinikum Münster - Albert Schweitzer Campus
RECRUITING
Münster
Klinikum Würzburg Mitte
RECRUITING
Würzburg
Poland
Centrum Medyczne NEUROMED
RECRUITING
Bydgoszcz
Local Institution - 0044
NOT_YET_RECRUITING
Bydgoszcz
Local Institution - 0061
WITHDRAWN
Gdansk
M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM
RECRUITING
Katowice
Pratia MCM Krakow
RECRUITING
Krakow
SP ZOZ Szpital Uniwersytecki w Krakowie
RECRUITING
Krakow
Instytut Zdrowia Dr Boczarska Jedynak
RECRUITING
Oświęcim
Local Institution - 0051
WITHDRAWN
Słomniki
Centrum Medyczne NeuroProtect
RECRUITING
Warsaw
Puerto Rico
Puerto Rico Multiple Sclerosis Center
RECRUITING
Caguas
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2027-06-09
Participants
Target number of participants: 200
Treatments
Experimental: Administration of BMS-986368 Dose A
Experimental: Administration of BMS-986368 Dose B
Experimental: Administration of BMS-986368 Dose C
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Celgene