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RecruitingPhase 2

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

Celgene · NCT06782490

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
200
US sites recruiting
14
Study start
June 5, 2025
Record last updated
October 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: BMS-986368; Placebo

Conditions: Multiple Sclerosis Spasticity

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Alabama Neurology Associates

    Birmingham, AL 35209

    Site contact: Emily Riser, Site 0033 · 205-803-2210

  • Perseverance Research Center,LLC

    Scottsdale, AZ 85253

    Site contact: Barry Hendin, Site 0050 · 602-258-3368

  • Aqualane Clinical Research

    Naples, FL 34105

    Site contact: Matthew Baker, Site 0068 · 239-529-6780

  • USF Health

    Tampa, FL 33612

    Site contact: Derrick Robertson, Site 0015 · 813-974-6378

  • University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Sharon Lynch, Site 0016 · 913-588-6980

  • Neurology Center of New England

    Foxborough, MA 02035

    Site contact: Andrew Taylor, Site 0049 · 781-551-5812

  • Northwest Neurology

    Southfield, MI 48034

    Site contact: Tessy Jenkins, Site 0071

  • Washington University School of Medicine

    St Louis, MO 63110

    Site contact: Robert Naismith, Site 0018 · 314-362-3293

  • University of Cincinnati Medical Center

    Cincinnati, OH 45219

    Site contact: Shahla Hosseini, Site 0002 · 412-427-7087

  • Riverside Methodist Hospital

    Columbus, OH 43214

    Site contact: Jacqueline Nicholas, Site 0039 · 614-566-1255

  • Thomas Jefferson University, Jefferson Headache Center

    Philadelphia, PA 19107

    Site contact: Thomas Leist, Site 0067 · 215-955-6871

  • Hope Neurology

    Knoxville, TN 37922

    Site contact: Sibyl Wray, Site 0003 · 865-218-6222

  • Prime Clinical Research

    Lewisville, TX 75067

    Site contact: Madhavi Thomas, Site 0072 · 817-907-7330

  • EvergreenHealth Medical Center

    Kirkland, WA 98034

    Site contact: Theodore Brown, Site 0001 · 425-899-5385

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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A Study to Evaluate the Efficacy, Safety and Tolerability of… (NCT06782490) | Bored Studies