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NCT Number: NCT06782490

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

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

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Key information

Conditions

Multiple Sclerosis Spasticity Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

John Hunter Hospital, Newcastle, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986368

Drug

Specified dose on specified days

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score

    Time frame: At week 6

Secondary outcomes

  1. Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score

    Time frame: At week 6

  2. Change from baseline on the MS Spasticity Scale (MSSS-88) total scores

    Time frame: At week 6

  3. Change from baseline on the Timed 25-Foot Walk (T25FW) score

    Time frame: At week 6

  4. Change from baseline on the Clinical Global Impression of Severity (CGI-S) score

    Time frame: At week 6

  5. Plasma concentrations of BMS-986368 at selected pre- and post-dose time points

    Time frame: Up to week 6

  6. Number of participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to week 16

  7. Serious adverse events (SAEs)

    Time frame: Up to week 16

  8. Adverse events (AEs) leading to treatment discontinuation

    Time frame: Up to week 16

  9. AEs leading to death

    Time frame: Up to week 16

  10. AEs leading to clinically significant lab abnormalities

    Time frame: Up to week 16

  11. Number of participants with suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to week 16

  12. Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS)

    Time frame: Up to week 15

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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)

Acronym: MSS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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