The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Specified dose on specified days
Specified dose on specified days
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score
Time frame: At week 6
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
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Local Institution - 0033
Birmingham, Alabama, United States
NOT_YET_RECRUITINGPerseverance Research Center,LLC
Scottsdale, Arizona, United States
RECRUITINGLocal Institution - 0017
Aurora, Colorado, United States
WITHDRAWNLocal Institution - 0068
Naples, Florida, United States
NOT_YET_RECRUITINGUSF Health
Tampa, Florida, United States
RECRUITINGUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITINGNeurology Center of New England
Foxborough, Massachusetts, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGUniversity of Cincinnati Medical Center
Cincinnati, Ohio, United States
RECRUITINGLocal Institution - 0039
Columbus, Ohio, United States
NOT_YET_RECRUITING...and 44 more locations
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