INTERVENTIONALRECRUITINGNCT06782490
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
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2026-10-27
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE2
- Enrollment
- 200 (ESTIMATED)
- Start date
- 2025-06-05
- Sponsor
- Celgene
- Design
- RANDOMIZED · PARALLEL · TREATMENT
- Locations
- 61
- Results record
- Not present in registry snapshot
Multiple Sclerosis SpasticitySpasticityMultiple SclerosisBMS-986368
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Cannabinoids and active compounds
No governed compound link was found.
Medicines
No exact medicine-name link was found.
Interventions
What was registered
DRUGBMS-986368
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Healthy volunteers
- Not accepted
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
primary outcomes
primary measures
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score
Time frame: At week 6
secondary outcomes
secondary measures
Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score
Time frame: At week 6
Change from baseline on the MS Spasticity Scale (MSSS-88) total scores
Time frame: At week 6
Change from baseline on the Timed 25-Foot Walk (T25FW) score
Time frame: At week 6
Change from baseline on the Clinical Global Impression of Severity (CGI-S) score
Time frame: At week 6
Plasma concentrations of BMS-986368 at selected pre- and post-dose time points
Time frame: Up to week 6
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to week 16
Serious adverse events (SAEs)
Time frame: Up to week 16
Adverse events (AEs) leading to treatment discontinuation
Time frame: Up to week 16
AEs leading to death
Time frame: Up to week 16
AEs leading to clinically significant lab abnormalities
Time frame: 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
Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS)
Time frame: Up to week 15
Publications
Locally readable linked articles
No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- 0cb91fa0-e0d2-438e-b311-ac028987d6c5
- Retrieved
- 27/10/2026, 13:19:12
- SHA-256
- 1c7cf6e8da7aff8ab7e3c93f7708dc21c3c82ffcf7023d9dedd4d4c21e588ed9
