RecruitingPhase 2NCT06782490

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

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)

Sponsor

Celgene

Enrollment

200 participants

Start Date

Jun 5, 2025

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis Spasticity

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BMS-986368 for reducing muscle spasticity (stiffness and involuntary tightness) in people with multiple sclerosis (MS). Spasticity can cause pain, difficulty moving, and reduced quality of life. **You may be eligible if...** - You have a confirmed diagnosis of multiple sclerosis - You have had significant spasticity due to MS for at least 6 months - Your spasticity is rated 2 or higher on the Modified Ashworth Scale in at least 2 muscle groups (at least one in the leg) - Your disability level falls within a moderate range (EDSS 3.0–6.5) **You may NOT be eligible if...** - You have another condition that causes spasticity - You had an MS relapse requiring treatment within the past 3 months - You have a history of substance use disorder - You are currently taking a spasticity medication that cannot be discontinued before starting the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986368

Specified dose on specified days

DRUGPlacebo

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, Ústí nad Labem Region, 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

View Full Details on ClinicalTrials.gov

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NCT06782490