A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
NCT ID: NCT06782490
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-06-05
2027-01-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Administration of BMS-986368 Dose A
BMS-986368
Specified dose on specified days
Administration of BMS-986368 Dose B
BMS-986368
Specified dose on specified days
Administration of BMS-986368 Dose C
BMS-986368
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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BMS-986368
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0033
Birmingham, Alabama, United States
Perseverance Research Center,LLC
Scottsdale, Arizona, United States
Local Institution - 0017
Aurora, Colorado, United States
Local Institution - 0068
Naples, Florida, United States
Local Institution - 0015
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
Local Institution - 0001
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
Local Institution - 0007
Box Hill, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Perron Institute
Nedlands, Western Australia, Australia
Local Institution - 0013
Edmonton, Alberta, Canada
Local Institution - 0024
London, Ontario, Canada
Local Institution - 0012
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
Local Institution - 0055
Brno, Brno-město, Czechia
Local Institution - 0010
Hradec Králové, Hradec Králové, Czechia
Local Institution - 0054
Prague, Praha 2, Czechia
Local Institution - 0059
Prague, Praha 4, Czechia
Local Institution - 0011
Prague, Praha 5, Czechia
Local Institution - 0053
Pardubice, , Czechia
Local Institution - 0009
Teplice, Ústecký kraj, Czechia
Klinikum Würzburg Mitte
Würzburg, Bavaria, Germany
Neurologischen Gemeinschaftspraxis Kassel und Vellmar
Kassel, Hesse, Germany
Local Institution - 0027
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
Local Institution - 0048
Oświęcim, Lesser Poland Voivodeship, Poland
Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0045
Katowice, Silesian Voivodeship, Poland
Local Institution - 0061
Gdansk, , Poland
Local Institution - 0051
Słomniki, , Poland
Puerto Rico Multiple Sclerosis Center
Caguas, , Puerto Rico
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Site 0033
Role: primary
Barry Hendin, Site 0050
Role: primary
Site 0068
Role: primary
Site 0015
Role: primary
Sharon Lynch, Site 0016
Role: primary
Andrew Taylor, Site 0049
Role: primary
Robert Naismith, Site 0018
Role: primary
Shahla Hosseini, Site 0002
Role: primary
Site 0039
Role: primary
Site 0069
Role: primary
Site 0067
Role: primary
Sibyl Wray, Site 0003
Role: primary
Site 0001
Role: primary
Jeannette Lechner-Scott, Site 0005
Role: primary
Michael Barnett, Site 0004
Role: primary
Andrew Lee, Site 0030
Role: primary
Site 0007
Role: primary
Marion Simpson, Site 0008
Role: primary
Mark Marriott, Site 0006
Role: primary
william Carroll, Site 0019
Role: primary
Site 0013
Role: primary
Site 0024
Role: primary
Site 0012
Role: primary
Site 0028
Role: primary
Donald Rivest, Site 0014
Role: primary
Adil Harroud, Site 0029
Role: primary
Site 0055
Role: primary
Site 0010
Role: primary
Site 0054
Role: primary
Site 0059
Role: primary
Site 0053
Role: primary
Site 0009
Role: primary
Mathias Mäurer, Site 0052
Role: primary
Christoph Lassek, Site 0022
Role: primary
Site 0027
Role: primary
Site 0060
Role: primary
Matthias Schwab, Site 0023
Role: primary
Matthias Böhringer, Site 0051
Role: primary
Tjalf Ziemssen, Site 0021
Role: primary
Site 0020
Role: primary
Pawel Lisewski, Site 0057
Role: primary
Site 0044
Role: primary
Paulina Kaczmarska, Site 0046
Role: primary
Agnieszka Slowik, Site 0056
Role: primary
Site 0048
Role: primary
Anna Karlinska, Site 0047
Role: primary
Site 0045
Role: primary
Jose Avila Ornelas, Site 0058
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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IM045-1018
Identifier Type: -
Identifier Source: org_study_id