Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants with Multiple Sclerosis Spasticity
type of intervention
Interventional, Randomised controlled trial (interventional)
recruitment status
Recruiting
region
NSW, SA, VIC, WA
type of ms
Primary progressive MS, Relapsing remitting MS, Secondary progressive MS
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
- 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.
- 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.
Recruitment commenced June 2025.
New South Wales Locations
Newcastle, New South Wales, Australia, 2305
John Hunter Hospital
Contact: Jeannette Lechner-Scott, Site 0005
+61 2 4042 0682
University of Sydney - Brain and Mind Research Institute (BMRI)
Contact: Michael Barnett, Site 0004
+61 2 9351 0704
South Australia Locations
Kent Town, South Australia, Australia, 5067
Centre for Neuroscience Innovation
Contact: Andrew Lee, Site 0030
+61 8 81320494
Victoria Locations
Box Hill, Victoria, Australia, 3128
Box Hill Hospital
Contact: Katherine Buzzard, Site 0007
+61 3 9094 9539
Heidelberg, Victoria, Australia, 3084
Austin Health
Contact: Marion Simpson, Site 0008
+61 3 94963705
Parkville, Victoria, Australia, 3050
The Royal Melbourne Hospital
Contact: Mark Marriott, Site 0006
+ 61 3 93429092
Western Australia Locations
Nedlands, Western Australia, Australia, 6009
Perron Institute
Contact: William Carroll, Site 0019
+61 8 6457 0213
Full details of the trial can be found on the ClinicalTrials.gov website here.
NSW, SA, VIC, WA.
Yes
25/05/2026
