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)
Celgene
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
Eligibility
- Age range
- 18–70 years
- Sex
- All
- 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 part…
Interventions
- DrugBMS-986368
Specified dose on specified days
- DrugPlacebo
Specified dose on specified days
Locations (54)
- Alabama Neurology AssociatesBirmingham, Alabama
- Perseverance Research Center,LLCScottsdale, Arizona
- Local Institution - 0017Aurora, Colorado
- Aqualane Clinical ResearchNaples, Florida
- USF HealthTampa, Florida
- University of Kansas Medical CenterKansas City, Kansas