Phase
Condition
Scar Tissue
Memory Loss
Neurologic Disorders
Treatment
Placebo
BMS-986368
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 Design
Connect with a study center
Local Institution - 0005
Newcastle, New South Wales 2305
AustraliaSite Not Available
Local Institution - 0004
Sydney, New South Wales 2050
AustraliaSite Not Available
Local Institution - 0030
Kent Town, South Australia 5067
AustraliaSite Not Available
Local Institution - 0007
Box Hill, Victoria 3128
AustraliaSite Not Available
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Local Institution - 0008
Heidelberg, Victoria 3084
AustraliaSite Not Available
Local Institution - 0006
Parkville, Victoria 3050
AustraliaSite Not Available
Local Institution - 0019
Nedlands, Western Australia 6009
AustraliaSite Not Available
Perron Institute
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Local Institution - 0013
Edmonton, Alberta T6G 2G3
CanadaSite Not Available
Local Institution - 0024
London, Ontario N6A 5A5
CanadaSite Not Available
Local Institution - 0012
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Local Institution - 0028
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Local Institution - 0014
Lévis, Quebec G6W0M5
CanadaSite Not Available
Local Institution - 0029
Montreal, Quebec H3A2B4
CanadaSite Not Available
Local Institution - 0055
Brno, Brno-město 656 91
CzechiaSite Not Available
Local Institution - 0010
Hradec Kralove, Hradec Králové 500 05
CzechiaSite Not Available
Local Institution - 0054
Prague, Praha 2 12111
CzechiaSite Not Available
Local Institution - 0059
Prague, Praha 4 14059
CzechiaSite Not Available
Local Institution - 0011
Praha, Praha 5 150 06
CzechiaSite Not Available
Local Institution - 0009
Teplice, Ústecký Kraj 415 01
CzechiaSite Not Available
Local Institution - 0053
Pardubice, 532 03
CzechiaSite Not Available
Local Institution - 0052
Wuerzburg, Bayern 97074
GermanySite Not Available
Local Institution - 0022
Kassel, Hessen 34121
GermanySite Not Available
Local Institution - 0027
Bochum, Nordrhein-Westfalen 44791
GermanySite Not Available
Local Institution - 0060
Münster, Nordrhein-Westfalen 48149
GermanySite Not Available
Local Institution - 0031
Meisenheim, Rheinland-Pfalz 55590
GermanySite Not Available
Local Institution - 0023
Jena, Thüringen 07747
GermanySite Not Available
Local Institution - 0051
Bielefeld, 33647
GermanySite Not Available
Local Institution - 0021
Dresden, 01307
GermanySite Not Available
Local Institution - 0020
Essen, 45122
GermanySite Not Available
Local Institution - 0044
Bydgoszcz, Kujawsko-pomorskie 85-796
PolandSite Not Available
Local Institution - 0057
Bydgoszcz, Kujawsko-pomorskie 85-163
PolandSite Not Available
Local Institution - 0047
Warszawa, MZ 01-684
PolandSite Not Available
Local Institution - 0046
Kraków, Małopolskie 30-727
PolandSite Not Available
Local Institution - 0056
Kraków, Małopolskie 31-503
PolandSite Not Available
Local Institution - 0048
Oswiecim, Małopolskie 32-600
PolandSite Not Available
Local Institution - 0045
Katowice, Śląskie 40-571
PolandSite Not Available
Local Institution - 0061
Gdańsk, 80-952
PolandSite Not Available
Local Institution - 0051
Slomniki, 32-090
PolandSite Not Available
Local Institution - 0058
Caguas, 00725
Puerto RicoSite Not Available
Puerto Rico Multiple Sclerosis Center
Caguas, 00725
Puerto RicoActive - Recruiting
Local Institution - 0050
Scottsdale, Arizona 85253
United StatesSite Not Available
Local Institution - 0017
Aurora, Colorado 80045
United StatesSite Not Available
Local Institution - 0015
Tampa, Florida 33612
United StatesSite Not Available
Local Institution - 0016
Kansas City, Kansas 66160
United StatesSite Not Available
Local Institution - 0049
Foxboro, Massachusetts 02035
United StatesSite Not Available
Neurology Center of New England
Foxboro, Massachusetts 02035
United StatesActive - Recruiting
Local Institution - 0018
Saint Louis, Missouri 63110
United StatesSite Not Available
Local Institution - 0002
Cincinnati, Ohio 45219
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Local Institution - 0039
Columbus, Ohio 43214
United StatesSite Not Available
Hope Neurology
Knoxville, Tennessee 37922
United StatesActive - Recruiting
Local Institution - 0003
Knoxville, Tennessee 37922
United StatesSite Not Available
Local Institution - 0001
Kirkland, Washington 98034
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.