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)

Condition studied

Multiple Sclerosis Spasticity

Investigational medicinal product(s)

Eligibility

Primary endpoint

The way we are measuring the main study goals (the main trial endpoint) is by looking at how much the stiffness in the person's most affected leg changes from the start of the study to the end of Week 6. We will use a tool called the Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) to measure this

Endpoint detail

The secondary trial endpoints include the Numeric Rating Scale-Spasticity (NRS-S), which is a question answered every day using an eDiary provided to the participant., Other secondary endpoints include the MS Spasticity Scale (MSSS-88), a set of questions asking about spasticity in the participant’s daily life, the Timed 25-Foot Walk (T25FW) test, a test to see how long it takes the participant to walk 25 feet, and the Clinical Global Impression of Severity, a question for the investigator to determine how severe the participant’s condition is.