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 (44) 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
Arizona
Perseverance Research Center,LLC
RECRUITING
Scottsdale
Colorado
Local Institution - 0017
WITHDRAWN
Aurora
Florida
Local Institution - 0068
NOT_YET_RECRUITING
Naples
Local Institution - 0015
NOT_YET_RECRUITING
Tampa
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Neurology Center of New England
RECRUITING
Foxborough
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Local Institution - 0039
NOT_YET_RECRUITING
Columbus
Pennsylvania
Local Institution - 0067
NOT_YET_RECRUITING
Philadelphia
Tennessee
Hope Neurology
RECRUITING
Knoxville
Washington
Local Institution - 0001
NOT_YET_RECRUITING
Kirkland
Other Locations
Australia
Local Institution - 0007
NOT_YET_RECRUITING
Box Hill
Austin Health
RECRUITING
Heidelberg
Local Institution - 0030
NOT_YET_RECRUITING
Kent Town
Perron Institute
RECRUITING
Nedlands
John Hunter Hospital
RECRUITING
Newcastle
Local Institution - 0006
NOT_YET_RECRUITING
Parkville
University of Sydney - Brain and Mind Research Institute (BMRI)
RECRUITING
Sydney
Canada
Local Institution - 0013
NOT_YET_RECRUITING
Edmonton
Centre de Recherche Saint-Louis
RECRUITING
Lévis
Local Institution - 0024
NOT_YET_RECRUITING
London
Montreal Neurological Institute and Hospital
RECRUITING
Montreal
Local Institution - 0012
NOT_YET_RECRUITING
Ottawa
Local Institution - 0028
NOT_YET_RECRUITING
Toronto
Germany
Local Institution - 0051
NOT_YET_RECRUITING
Bielefeld
Local Institution - 0027
NOT_YET_RECRUITING
Bochum
Local Institution - 0021
NOT_YET_RECRUITING
Dresden
Local Institution - 0020
NOT_YET_RECRUITING
Essen
Local Institution - 0023
NOT_YET_RECRUITING
Jena
Local Institution - 0022
NOT_YET_RECRUITING
Kassel
Local Institution - 0031
WITHDRAWN
Meisenheim
Local Institution - 0060
NOT_YET_RECRUITING
Münster
Local Institution - 0052
NOT_YET_RECRUITING
Würzburg
Poland
Local Institution - 0044
NOT_YET_RECRUITING
Bydgoszcz
Local Institution - 0057
NOT_YET_RECRUITING
Bydgoszcz
Local Institution - 0061
WITHDRAWN
Gdansk
Local Institution - 0045
NOT_YET_RECRUITING
Katowice
Local Institution - 0046
NOT_YET_RECRUITING
Krakow
Local Institution - 0056
NOT_YET_RECRUITING
Krakow
Local Institution - 0048
NOT_YET_RECRUITING
Oświęcim
Local Institution - 0051
WITHDRAWN
Słomniki
Local Institution - 0047
NOT_YET_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 the NCT# and Site#
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2027-01-27
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