NCT06782490

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity

Conditions

• Multiple Sclerosis Spasticity

Interventions

Type	Name	Description
DRUG	BMS-986368	Specified dose on specified days
DRUG	Placebo	Specified dose on specified days

Timeline

• Start date: 2025-06-05
• Primary completion: 2027-05-26
• Completion: 2027-06-09
• First posted: 2025-01-20
• Last updated: 2026-03-25

Locations

53 sites across 7 countries: United States, Australia, Canada, Czechia, Germany, Poland, Puerto Rico

Regulatory

• FDA-regulated drug study