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Recruiting NCT06782490

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

Phase II Interventional Multiple Sclerosis Spasticity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986368, Placebo.
Who it may be relevant to
Registry conditions: Multiple Sclerosis Spasticity. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, Czechia, Germany +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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

Interventions

  • Drug BMS-986368
    Specified dose on specified days
  • Drug Placebo
    Specified dose on specified days

Primary outcome measures

  • Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score [Time frame: At week 6]
Secondary outcome measures (12)
  • Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score [Time frame: At week 6]
  • Change from baseline on the MS Spasticity Scale (MSSS-88) total scores [Time frame: At week 6]
  • Change from baseline on the Timed 25-Foot Walk (T25FW) score [Time frame: At week 6]
  • Change from baseline on the Clinical Global Impression of Severity (CGI-S) score [Time frame: At week 6]
  • Plasma concentrations of BMS-986368 at selected pre- and post-dose time points [Time frame: Up to week 6]
  • Number of participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to week 16]
  • Serious adverse events (SAEs) [Time frame: Up to week 16]
  • Adverse events (AEs) leading to treatment discontinuation [Time frame: Up to week 16]
  • AEs leading to death [Time frame: Up to week 16]
  • AEs leading to clinically significant lab abnormalities [Time frame: Up to week 16]
  • 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]
  • Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS) [Time frame: Up to week 15]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 15 centers
  • Alabama Neurology Associates — Birmingham
  • Perseverance Research Center,LLC — Scottsdale
  • Local Institution - 0017 — Aurora
  • Aqualane Clinical Research — Naples
  • USF Health — Tampa
  • University of Kansas Medical Center — Kansas City
  • Neurology Center of New England — Foxborough
  • Local Institution - 0071 — Southfield
  • … and 7 more centers
Germany · 9 centers
  • Klinikum Würzburg Mitte — Würzburg
  • Neurologischen Gemeinschaftspraxis Kassel und Vellmar — Kassel
  • St. Josef und St. Elisabeth Hospital gGmbH — Bochum
  • Universitätsklinikum Münster - Albert Schweitzer Campus — Münster
  • Local Institution - 0031 — Meisenheim
  • Universitätsklinikum Jena — Jena
  • Neurozentrum Bielefeld — Bielefeld
  • Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
  • … and 1 more center
Poland · 9 centers
  • Centrum Medyczne NEUROMED — Bydgoszcz
  • Local Institution - 0044 — Bydgoszcz
  • Pratia MCM Krakow — Krakow
  • SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow
  • Instytut Zdrowia Dr Boczarska Jedynak — Oświęcim
  • Centrum Medyczne NeuroProtect — Warsaw
  • Local Institution - 0061 — Gdansk
  • M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM — Katowice
  • … and 1 more center
Australia · 7 centers
  • John Hunter Hospital — Newcastle
  • University of Sydney - Brain and Mind Research Institute (BMRI) — Sydney
  • Centre for Neuroscience Innovation — Kent Town
  • Box Hill Hospital — Box Hill
  • Austin Health — Heidelberg
  • The Royal Melbourne Hospital — Parkville
  • Perron Institute — Nedlands
Czechia · 7 centers
  • Fakultni Nemocnice u sv. Anny v Brne — Brno
  • Fakultni nemocnice Hradec Kralove — Hradec Králové
  • Vseobecna fakultni nemocnice v Praze — Prague
  • Fakultni Thomayerova nemocnice — Prague
  • Local Institution - 0011 — Prague
  • Nemocnice Pardubického kraje — Pardubice
  • Nemocnice Teplice — Teplice
Canada · 6 centers
  • University Of Alberta Hospital — Edmonton
  • University Hospital - London Health Sciences Centre — London
  • The Ottawa Hospital - General Campus — Ottawa
  • Unity Health Toronto, St. Michael's Hospital — Toronto
  • Centre de Recherche Saint-Louis — Lévis
  • Montreal Neurological Institute and Hospital — Montreal
Puerto Rico · 1 center
  • Puerto Rico Multiple Sclerosis Center — Caguas

Identifiers

NCT: NCT06782490 · IM045-1018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗