MSFrontier

MSS

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)
RecruitingPhase 2MS (type not specified)NCT067824902024-517745-14-00

What it found

Still running

No result yet.

What was tested

Treatment tested

  • BMS-986368
  • CC-97489

Placebo or sham

  • Placebo
  • CC-97489 1mg , CC-97489 3mg

What it measured

Main measures

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

    At week 6

    Spasticity

  • The way we are measuring the main study goals (the main trial endpoint) is by looking at how much the stiffness in the person's most affected leg changes from the start of the study to the end of Week 6. We will use a tool called the Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) to measure this

    Spasticity

Other measures (14)

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

    At week 6

    Spasticity

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

    At week 6

    Spasticity

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

    At week 6

    Disability progressionWalking and mobility

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

    At week 6

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

    Up to week 6

    How the body handles the medicine

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

    Up to week 16

    Safety

  • Serious adverse events (SAEs)

    Up to week 16

    Safety

  • Adverse events (AEs) leading to treatment discontinuation

    Up to week 16

    Safety

  • AEs leading to death

    Up to week 16

  • AEs leading to clinically significant lab abnormalities

    Up to week 16

Who could take part

MS (type not specified) · 18 to 70

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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

Papers

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    History

      1. Started

        Jun 2025

      2. Main results due

        May 2027

      3. Finished

        Jun 2027

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