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

Launched by CELGENE · Jan 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BMS-986368 to see how well it works, how safe it is, and how well people can tolerate it for treating spasticity in individuals with Multiple Sclerosis (MS). Spasticity is a condition that causes stiffness and tightness in the muscles, which can affect movement and comfort. The trial is not yet recruiting participants, but it will involve adults aged between 18 and 75 who have been diagnosed with MS and have experienced spasticity for at least six months.

To participate, individuals must meet certain criteria, such as having a specific level of muscle stiffness and a certain level of disability related to their MS. Participants should not have other medical conditions that could affect their spasticity or be using certain medications that could interfere with the study. If eligible, participants can expect to undergo assessments to monitor their muscle stiffness and overall health throughout the trial. This study aims to help improve treatment options for people with MS, and participants will play an important role in advancing our understanding of how to manage spasticity in this condition.

Gender

ALL

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.