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

Purpose

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

Condition

  • Multiple Sclerosis Spasticity

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

Alabama Neurology Associates
Birmingham, Alabama 35209
Contact:
Emily Riser, Site 0033
205-803-2210

Perseverance Research Center,LLC
Scottsdale, Arizona 85253
Contact:
Barry Hendin, Site 0050
602-258-3368

Aqualane Clinical Research
Naples, Florida 34105
Contact:
Matthew Baker, Site 0068
239-529-6780

USF Health
Tampa, Florida 33612
Contact:
Derrick Robertson, Site 0015
813-974-6378

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

Neurology Center of New England
Foxborough, Massachusetts 02035
Contact:
Andrew Taylor, Site 0049
781-551-5812

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Robert Naismith, Site 0018
314-362-3293

University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Contact:
Shahla Hosseini, Site 0002
412-427-7087

Riverside Methodist Hospital
Columbus, Ohio 43214
Contact:
Jacqueline Nicholas, Site 0039
614-566-1255

Hope Neurology
Knoxville, Tennessee 37922
Contact:
Sibyl Wray, Site 0003
865-218-6222

EvergreenHealth Medical Center
Kirkland, Washington 98034
Contact:
Theodore Brown, Site 0001
425-899-5385

Puerto Rico Multiple Sclerosis Center
Caguas, Puerto Rico 00725
Contact:
Jose Avila Ornelas, Site 0058
787-930-1705

More Details

Status
Recruiting
Sponsor
Celgene

Study Contact

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