RightFit
RecruitingPhase 2

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests BMS-986368 for people with multiple sclerosis (MS) who have spasticity, or stiff, tight muscles. It looks at how well the drug works, how safe it is, and how well people can tolerate it.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must have a diagnosis of multiple sclerosis (MS).
  • You must have had stiff, tight muscles caused by MS for at least 6 months before Visit 1.
  • At Visit 1, you must score at least 2 on the Modified Ashworth Scale, a muscle stiffness test, in each of 2 muscle groups. At least one must be in the leg, not counting muscles that point the foot downward.
  • At Visit 1, you must score 3.0–6.5 on the Expanded Disability Status Scale (EDSS), which measures disability from MS.

Who can't join

  • You cannot have another illness or condition that causes or affects muscle stiffness.
  • You cannot have an MS flare-up that needs treatment or a change in your MS drug dose within 3 months of Visit 1 or Visit 2.
  • You cannot have a history of a drug or alcohol use disorder under the study’s DSM-5 diagnostic rules.
  • You cannot be taking a muscle stiffness medicine that you cannot stop and allow time to clear from your body by Visit 2.
  • You cannot have used medicines called FAAH/MAGL inhibitors or cannabis-related products, including cannabis, CBD, or THC, within 30 days before Visit 1.
  • Other study rules for who can join also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 participant's level of spasticity. * Participants must not have an acute MS exacerbation/relapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2. * Participants must not have a history of any substance abuse disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic Criteria for Drug and Alcohol Abuse. * Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2. * Participants must not have used FAAH/MAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to Visit 1. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study sites (16)

AL

AZ

CO

FL

KS

MA

MI

MO

OH

PA

TN

TX

WA