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

May 6, 2026 updated by: Celgene

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2305
        • Recruiting
        • John Hunter Hospital
        • Contact:
          • Jeannette Lechner-Scott, Site 0005
          • Phone Number: +61 2 4042 0682
      • Sydney, New South Wales, Australia, 2050
        • Recruiting
        • University of Sydney - Brain and Mind Research Institute (BMRI)
        • Contact:
          • Michael Barnett, Site 0004
          • Phone Number: +61 2 9351 0704
    • South Australia
      • Kent Town, South Australia, Australia, 5067
        • Recruiting
        • Centre for Neuroscience Innovation
        • Contact:
          • Andrew Lee, Site 0030
          • Phone Number: +61 8 81320494
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
        • Contact:
          • Katherine Buzzard, Site 0007
          • Phone Number: +61 3 9094 9527
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health
        • Contact:
          • Marion Simpson, Site 0008
          • Phone Number: +61 3 94963705
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital
        • Contact:
          • Mark Marriott, Site 0006
          • Phone Number: + 61 3 93429092
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Perron Institute
        • Contact:
          • william Carroll, Site 0019
          • Phone Number: +61 8 6457 0213
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G3
        • Recruiting
        • University of Alberta Hospital
        • Contact:
          • Gregg Blevins, Site 0013
          • Phone Number: 780-248-5895
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • University Hospital - London Health Sciences Centre
        • Contact:
          • Juan Racosta, Site 0024
          • Phone Number: 519 685 8500x35520
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus
        • Contact:
          • Mark Freedman, Site 0012
          • Phone Number: 613-737-8104
      • Toronto, Ontario, Canada, M5B 1W8
        • Not yet recruiting
        • Local Institution - 0028
        • Contact:
          • Site 0028
    • Quebec
      • Lévis, Quebec, Canada, G6W0M5
        • Recruiting
        • Centre de Recherche Saint-Louis
        • Contact:
          • Donald Rivest, Site 0014
          • Phone Number: 418-780-3501x2703
      • Montreal, Quebec, Canada, H3A2B4
        • Recruiting
        • Montreal Neurological Institute and Hospital
        • Contact:
          • Adil Harroud, Site 0029
          • Phone Number: (514) 396-2950
  • Czechia
      • Pardubice, Czechia, 532 03
        • Recruiting
        • Nemocnice Pardubického kraje
        • Contact:
          • Miroslav Mares, Site 0053
          • Phone Number: +420 466 014 732
    • Brno-město
      • Brno, Brno-město, Czechia, 656 91
        • Recruiting
        • Fakultni nemocnice u sv. Anny v Brne
        • Contact:
          • Martin Pail, Site 0055
          • Phone Number: +420 543 182 658
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
        • Contact:
          • Zbyšek Pavelek, Site 0010
          • Phone Number: +420 495 831 111
    • Praha 2
      • Prague, Praha 2, Czechia, 12111
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
        • Contact:
          • Ivana Kovářová, Site 0054
          • Phone Number: +420 224 961 111
    • Praha 4
      • Prague, Praha 4, Czechia, 14059
        • Recruiting
        • Fakultni Thomayerova nemocnice
        • Contact:
          • Marketa Grunermelova, Site 0059
          • Phone Number: +420 543 182 658
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Withdrawn
        • Local Institution - 0011
    • Ústí nad Labem Region
      • Teplice, Ústí nad Labem Region, Czechia, 415 01
        • Recruiting
        • Nemocnice Teplice
        • Contact:
          • Marta Vachová, Site 0009
          • Phone Number: +420 417 519 625
  • Germany
      • Bielefeld, Germany, 33647
        • Recruiting
        • Neurozentrum Bielefeld
        • Contact:
          • Matthias Böhringer, Site 0051
          • Phone Number: 0049521443069
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden
        • Contact:
          • Tjalf Ziemssen, Site 0021
          • Phone Number: +4917610315216
      • Essen, Germany, 45122
        • Withdrawn
        • Local Institution - 0020
    • Bavaria
      • Würzburg, Bavaria, Germany, 97074
        • Recruiting
        • Klinikum Würzburg Mitte
        • Contact:
          • Mathias Mäurer, Site 0052
          • Phone Number: 00499313935700
    • Hesse
      • Kassel, Hesse, Germany, 34121
        • Recruiting
        • Neurologischen Gemeinschaftspraxis Kassel und Vellmar
        • Contact:
          • Christoph Lassek, Site 0022
          • Phone Number: 004956171611
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44791
        • Recruiting
        • St. Josef und St. Elisabeth Hospital gGmbH
        • Contact:
          • Simon Faissner, Site 0027
          • Phone Number: 00492345092441
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster - Albert Schweitzer Campus
        • Contact:
          • Luisa Klotz, Site 0060
          • Phone Number: 00492518348165
    • Rhineland-Palatinate
      • Meisenheim, Rhineland-Palatinate, Germany, 55590
        • Withdrawn
        • Local Institution - 0031
    • Thuringia
      • Jena, Thuringia, Germany, 07747
        • Recruiting
        • Universitätsklinikum Jena
        • Contact:
          • Matthias Schwab, Site 0023
          • Phone Number: +4936419323486
  • Poland
      • Gdansk, Poland, 80-952
        • Withdrawn
        • Local Institution - 0061
      • Katowice, Poland, 40-571
        • Recruiting
        • M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM
        • Contact:
          • Katarzyna Maciejowska, Site 0045
          • Phone Number: 665041418
      • Słomniki, Poland, 32-090
        • Withdrawn
        • Local Institution - 0051
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Not yet recruiting
        • Local Institution - 0044
        • Contact:
          • Site 0044
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-163
        • Recruiting
        • Centrum Medyczne Neuromed
        • Contact:
          • Pawel Lisewski, Site 0057
          • Phone Number: 0048698619497
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-727
        • Recruiting
        • Pratia McM Krakow
        • Contact:
          • Paulina Kaczmarska, Site 0046
          • Phone Number: +48122954100
      • Krakow, Lesser Poland Voivodeship, Poland, 31-503
        • Recruiting
        • SP ZOZ Szpital Uniwersytecki w Krakowie
        • Contact:
          • Agnieszka Slowik, Site 0056
          • Phone Number: +48607685751
      • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
        • Recruiting
        • Instytut Zdrowia Dr Boczarska Jedynak
        • Contact:
          • Magdalena Boczarska-Jedynak, Site 0048
          • Phone Number: +48-501-485-317
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-684
        • Recruiting
        • Centrum Medyczne NeuroProtect
        • Contact:
          • Anna Karlinska, Site 0047
          • Phone Number: +48660517184
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Recruiting
        • Puerto Rico Multiple Sclerosis Center
        • Contact:
          • Jose Avila Ornelas, Site 0058
          • Phone Number: 787-930-1705
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Alabama Neurology Associates
        • Contact:
          • Emily Riser, Site 0033
          • Phone Number: 205-803-2210
    • Arizona
      • Scottsdale, Arizona, United States, 85253
        • Recruiting
        • Perseverance Research Center,LLC
        • Contact:
          • Barry Hendin, Site 0050
          • Phone Number: 602-258-3368
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Withdrawn
        • Local Institution - 0017
    • Florida
      • Naples, Florida, United States, 34105
        • Recruiting
        • Aqualane Clinical Research
        • Contact:
          • Matthew Baker, Site 0068
          • Phone Number: 239-529-6780
      • Tampa, Florida, United States, 33612
        • Recruiting
        • USF Health
        • Contact:
          • Derrick Robertson, Site 0015
          • Phone Number: 813-974-6378
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
          • Sharon Lynch, Site 0016
          • Phone Number: 913-588-6980
    • Massachusetts
      • Foxborough, Massachusetts, United States, 02035
        • Recruiting
        • Neurology Center of New England
        • Contact:
          • Andrew Taylor, Site 0049
          • Phone Number: 781-551-5812
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Robert Naismith, Site 0018
          • Phone Number: 314-362-3293
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
          • Shahla Hosseini, Site 0002
          • Phone Number: 412-427-7087
      • Columbus, Ohio, United States, 43214
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Columbus, Ohio, United States, 43235
        • Withdrawn
        • Local Institution - 0069
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Local Institution - 0067
        • Contact:
          • Site 0067
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Recruiting
        • Hope Neurology
        • Contact:
          • Sibyl Wray, Site 0003
          • Phone Number: 865-218-6222
    • Washington
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • EvergreenHealth Medical Center
        • Contact:
          • Theodore Brown, Site 0001
          • Phone Number: 425-899-5385

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Specified dose on specified days
Experimental: Administration of BMS-986368 Dose A
Drug: BMS-986368
Specified dose on specified days
Experimental: Administration of BMS-986368 Dose B
Drug: BMS-986368
Specified dose on specified days
Experimental: Administration of BMS-986368 Dose C
Drug: BMS-986368
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score
Time Frame: At week 6
At week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score
Time Frame: At week 6
At week 6
Change from baseline on the MS Spasticity Scale (MSSS-88) total scores
Time Frame: At week 6
At week 6
Change from baseline on the Timed 25-Foot Walk (T25FW) score
Time Frame: At week 6
At week 6
Plasma concentrations of BMS-986368 at selected pre- and post-dose time points
Time Frame: Up to week 6
Up to week 6
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to week 16
Up to week 16
Serious adverse events (SAEs)
Time Frame: Up to week 16
Up to week 16
Adverse events (AEs) leading to treatment discontinuation
Time Frame: Up to week 16
Up to week 16
AEs leading to death
Time Frame: Up to week 16
Up to week 16
AEs leading to clinically significant lab abnormalities
Time Frame: Up to week 16
Up to week 16
Number of participants with suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to week 16
Up to week 16
Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS)
Time Frame: Up to week 15
Up to week 15
Change from baseline on the Clinical Global Impression of Severity (CGI-S) score
Time Frame: At week 6
At week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2025

Primary Completion (Estimated)

May 26, 2027

Study Completion (Estimated)

June 9, 2027

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM045-1018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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