Ireland
--:--IST
Recruiting Phase 2

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

NCT06782490 · tracked via the Priya Life Science Poland tracker
Sponsor
Phase
Phase 2
Started
2025-06-05
Last updated
2026-10-01

Condition(s) studied

Multiple Sclerosis Spasticity

Investigational drug(s) / intervention(s)

BMS-986368 →Placebo

BMS-986368: Specified dose on specified days

Placebo: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
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.

Primary outcome measure(s)

  • Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score — At week 6

Trial sites (58)

FacilityCityRegionStatus
Alabama Neurology Associates Birmingham Alabama Recruiting
Perseverance Research Center,LLC Scottsdale Arizona Recruiting
Local Institution - 0017 Aurora Colorado Withdrawn
Aqualane Clinical Research Naples Florida Recruiting
USF Health Tampa Florida Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Neurology Center of New England Foxborough Massachusetts Recruiting
Northwest Neurology Southfield Michigan Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
Riverside Methodist Hospital Columbus Ohio Recruiting
Local Institution - 0069 Columbus Ohio Withdrawn
Thomas Jefferson University, Jefferson Headache Center Philadelphia Pennsylvania Recruiting
Hope Neurology Knoxville Tennessee Recruiting
Prime Clinical Research Lewisville Texas Recruiting
EvergreenHealth Medical Center Kirkland Washington Recruiting
John Hunter Hospital Newcastle New South Wales Recruiting
University of Sydney - Brain and Mind Research Institute (BMRI) Sydney New South Wales Recruiting
Centre for Neuroscience Innovation Kent Town South Australia Recruiting
Box Hill Hospital Box Hill Victoria Recruiting
Austin Health Heidelberg Victoria Recruiting
The Royal Melbourne Hospital Parkville Victoria Recruiting
Perron Institute Nedlands Western Australia Recruiting
University Of Alberta Hospital Edmonton Alberta Recruiting
University Hospital - London Health Sciences Centre London Ontario Recruiting
The Ottawa Hospital - General Campus Ottawa Ontario Recruiting
Unity Health Toronto, St. Michael's Hospital Toronto Ontario Recruiting
Centre de Recherche Saint-Louis Lévis Quebec Recruiting
Montreal Neurological Institute and Hospital Montreal Quebec Recruiting
Fakultni Nemocnice u sv. Anny v Brne Brno Brno-město Recruiting
Fakultni nemocnice Hradec Kralove Hradec Králové Hradec Králové Recruiting
Vseobecna fakultni nemocnice v Praze Prague Praha 2 Recruiting
Fakultni Thomayerova nemocnice Prague Praha 4 Recruiting
Local Institution - 0011 Prague Praha 5 Withdrawn
Nemocnice Pardubického kraje Pardubice Czechia Recruiting
Local Institution - 0077 Zlín Czechia Not Yet Recruiting
Nemocnice Teplice Teplice Ústí nad Labem Region Recruiting
Klinikum Würzburg Mitte Würzburg Bavaria Recruiting
Neurologischen Gemeinschaftspraxis Kassel und Vellmar Kassel Hesse Recruiting
St. Josef und St. Elisabeth Hospital gGmbH Bochum North Rhine-Westphalia Recruiting

+ 18 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06782490 on ClinicalTrials.gov ↗ ← All trials in Poland