Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT06782490

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

Led by Celgene · Updated on 2026-05-07

200

Participants Needed

54

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 62;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.
Not Eligible

You will not qualify if you...

  • 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 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 54 locations

1

Alabama Neurology Associates

Birmingham, Alabama, United States, 35209

Actively Recruiting

2

Perseverance Research Center,LLC

Scottsdale, Arizona, United States, 85253

Actively Recruiting

3

Local Institution - 0017

Aurora, Colorado, United States, 80045

Withdrawn

4

Aqualane Clinical Research

Naples, Florida, United States, 34105

Actively Recruiting

5

USF Health

Tampa, Florida, United States, 33612

Actively Recruiting

6

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

7

Neurology Center of New England

Foxborough, Massachusetts, United States, 02035

Actively Recruiting

8

Local Institution - 0071

Southfield, Michigan, United States, 48034

Not Yet Recruiting

9

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

10

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

11

Local Institution - 0039

Columbus, Ohio, United States, 43214

Not Yet Recruiting

12

Local Institution - 0069

Columbus, Ohio, United States, 43235

Withdrawn

13

Local Institution - 0067

Philadelphia, Pennsylvania, United States, 19107

Not Yet Recruiting

14

Hope Neurology

Knoxville, Tennessee, United States, 37922

Actively Recruiting

15

EvergreenHealth Medical Center

Kirkland, Washington, United States, 98034

Actively Recruiting

16

John Hunter Hospital

Newcastle, New South Wales, Australia, 2305

Actively Recruiting

17

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

Sydney, New South Wales, Australia, 2050

Actively Recruiting

18

Centre for Neuroscience Innovation

Kent Town, South Australia, Australia, 5067

Actively Recruiting

19

Box Hill Hospital

Box Hill, Victoria, Australia, 3128

Actively Recruiting

20

Austin Health

Heidelberg, Victoria, Australia, 3084

Actively Recruiting

21

The Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Actively Recruiting

22

Perron Institute

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

23

University Of Alberta Hospital

Edmonton, Alberta, Canada, T6G 2G3

Actively Recruiting

24

University Hospital - London Health Sciences Centre

London, Ontario, Canada, N6A 5A5

Actively Recruiting

25

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

26

Local Institution - 0028

Toronto, Ontario, Canada, M5B 1W8

Not Yet Recruiting

27

Centre de Recherche Saint-Louis

Lévis, Quebec, Canada, G6W0M5

Actively Recruiting

28

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada, H3A2B4

Actively Recruiting

29

Fakultni Nemocnice u sv. Anny v Brne

Brno, Brno-město, Czechia, 656 91

Actively Recruiting

30

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové, Czechia, 500 05

Actively Recruiting

31

Vseobecna fakultni nemocnice v Praze

Prague, Praha 2, Czechia, 12111

Actively Recruiting

32

Fakultni Thomayerova nemocnice

Prague, Praha 4, Czechia, 14059

Actively Recruiting

33

Local Institution - 0011

Prague, Praha 5, Czechia, 150 06

Withdrawn

34

Nemocnice Pardubického kraje

Pardubice, Czechia, 532 03

Actively Recruiting

35

Nemocnice Teplice

Teplice, Ústí nad Labem Region, Czechia, 415 01

Actively Recruiting

36

Klinikum Würzburg Mitte

Würzburg, Bavaria, Germany, 97074

Actively Recruiting

37

Neurologischen Gemeinschaftspraxis Kassel und Vellmar

Kassel, Hesse, Germany, 34121

Actively Recruiting

38

St. Josef und St. Elisabeth Hospital gGmbH

Bochum, North Rhine-Westphalia, Germany, 44791

Actively Recruiting

39

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany, 48149

Actively Recruiting

40

Local Institution - 0031

Meisenheim, Rhineland-Palatinate, Germany, 55590

Withdrawn

41

Universitätsklinikum Jena

Jena, Thuringia, Germany, 07747

Actively Recruiting

42

Neurozentrum Bielefeld

Bielefeld, Germany, 33647

Actively Recruiting

43

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany, 01307

Actively Recruiting

44

Local Institution - 0020

Essen, Germany, 45122

Withdrawn

45

Centrum Medyczne NEUROMED

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-163

Actively Recruiting

46

Local Institution - 0044

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796

Not Yet Recruiting

47

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, Poland, 30-727

Actively Recruiting

48

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, Poland, 31-503

Actively Recruiting

49

Instytut Zdrowia Dr Boczarska Jedynak

Oświęcim, Lesser Poland Voivodeship, Poland, 32-600

Actively Recruiting

50

Centrum Medyczne NeuroProtect

Warsaw, Masovian Voivodeship, Poland, 01-684

Actively Recruiting

51

Local Institution - 0061

Gdansk, Poland, 80-952

Withdrawn

52

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

Katowice, Poland, 40-571

Actively Recruiting

53

Local Institution - 0051

Słomniki, Poland, 32-090

Withdrawn

54

Puerto Rico Multiple Sclerosis Center

Caguas, Puerto Rico, 00725

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

First line of the email MUST contain NCT # and Site #.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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