Multiple Sclerosis Spasticity
Conditions
Keywords
Spasticity, Multiple Sclerosis, BMS-986368
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
Interventions
DRUGBMS-986368
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score | At week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score | At week 6 |
| Change from baseline on the MS Spasticity Scale (MSSS-88) total scores | At week 6 |
| Change from baseline on the Timed 25-Foot Walk (T25FW) score | At week 6 |
| Change from baseline on the Clinical Global Impression of Severity (CGI-S) score | At week 6 |
| Plasma concentrations of BMS-986368 at selected pre- and post-dose time points | Up to week 6 |
| Number of participants with Treatment-Emergent Adverse Events (TEAEs) | Up to week 16 |
| Serious adverse events (SAEs) | Up to week 16 |
| Adverse events (AEs) leading to treatment discontinuation | Up to week 16 |
| AEs leading to death | Up to week 16 |
| AEs leading to clinically significant lab abnormalities | 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) | Up to week 16 |
| Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS) | Up to week 15 |
Countries
Australia, Canada, Czechia, Germany, Poland, Puerto Rico, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed