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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts 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 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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Administration of BMS-986368 Dose A
  • Drug: BMS-986368
    Specified dose on specified days
Experimental
Administration of BMS-986368 Dose B
  • Drug: BMS-986368
    Specified dose on specified days
Experimental
Administration of BMS-986368 Dose C
  • Drug: BMS-986368
    Specified dose on specified days
Placebo Comparator
Placebo
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Contact:
Sharon Lynch, Site 0016
913-588-6980

More Details

Status
Recruiting
Sponsor
Celgene

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.