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NCT06782490PHASE2Recruiting

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

Celgene

Start Date

6/5/2025

Completion Date

6/9/2027

Summary

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

Eligibility Criteria

Age Range: 18 years to 70 years

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.

Interventions

DRUG

BMS-986368

DRUG

Placebo

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Conditions

Multiple Sclerosis Spasticity

Locations

Alabama Neurology Associates

Birmingham, Alabama 35209

United States

Perseverance Research Center,LLC

Scottsdale, Arizona 85253

United States

Local Institution - 0017

Aurora, Colorado 80045

United States

Aqualane Clinical Research

Naples, Florida 34105

United States

USF Health

Tampa, Florida 33612

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Neurology Center of New England

Foxborough, Massachusetts 02035

United States

Local Institution - 0071

Southfield, Michigan 48034

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Riverside Methodist Hospital

Columbus, Ohio 43214

United States

Local Institution - 0069

Columbus, Ohio 43235

United States

Local Institution - 0067

Philadelphia, Pennsylvania 19107

United States

Hope Neurology

Knoxville, Tennessee 37922

United States

EvergreenHealth Medical Center

Kirkland, Washington 98034

United States

John Hunter Hospital

Newcastle, New South Wales 2305

Australia

University of Sydney - Brain and Mind Research Institute (BMRI)

Sydney, New South Wales 2050

Australia

Centre for Neuroscience Innovation

Kent Town, South Australia 5067

Australia

Box Hill Hospital

Box Hill, Victoria 3128

Australia

Austin Health

Heidelberg, Victoria 3084

Australia

The Royal Melbourne Hospital

Parkville, Victoria 3050

Australia

Perron Institute

Nedlands, Western Australia 6009

Australia

University Of Alberta Hospital

Edmonton, Alberta T6G 2G3

Canada

University Hospital - London Health Sciences Centre

London, Ontario N6A 5A5

Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario K1H 8L6

Canada

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario M5B 1W8

Canada

Centre de Recherche Saint-Louis

Lévis, Quebec G6W0M5

Canada

Montreal Neurological Institute and Hospital

Montreal, Quebec H3A2B4

Canada

Fakultni Nemocnice u sv. Anny v Brne

Brno, Brno-město 656 91

Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové 500 05

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Praha 2 12111

Czechia

Fakultni Thomayerova nemocnice

Prague, Praha 4 14059

Czechia

Local Institution - 0011

Prague, Praha 5 150 06

Czechia

Nemocnice Pardubického kraje

Pardubice, 532 03

Czechia

Nemocnice Teplice

Teplice, Ústí nad Labem Region 415 01

Czechia

Klinikum Würzburg Mitte

Würzburg, Bavaria 97074

Germany

Neurologischen Gemeinschaftspraxis Kassel und Vellmar

Kassel, Hesse 34121

Germany

St. Josef und St. Elisabeth Hospital gGmbH

Bochum, North Rhine-Westphalia 44791

Germany

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia 48149

Germany

Local Institution - 0031

Meisenheim, Rhineland-Palatinate 55590

Germany

Universitätsklinikum Jena

Jena, Thuringia 07747

Germany

Neurozentrum Bielefeld

Bielefeld, 33647

Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307

Germany

Local Institution - 0020

Essen, 45122

Germany

Centrum Medyczne NEUROMED

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-163

Poland

Local Institution - 0044

Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796

Poland

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship 30-727

Poland

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship 31-503

Poland

Instytut Zdrowia Dr Boczarska Jedynak

Oświęcim, Lesser Poland Voivodeship 32-600

Poland

Centrum Medyczne NeuroProtect

Warsaw, Masovian Voivodeship 01-684

Poland

Local Institution - 0061

Gdansk, 80-952

Poland

M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM

Katowice, 40-571

Poland

Local Institution - 0051

Słomniki, 32-090

Poland

Puerto Rico Multiple Sclerosis Center

Caguas, 00725

Puerto Rico