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)

简要总结

主要结局

次要结局

• 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)
• AEs leading to death(Up to week 16)
• Adverse events (AEs) leading to treatment discontinuation(Up to week 16)
• AEs leading to clinically significant lab abnormalities(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)
• 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)