Clinical Trials in the USA / NCT06782490
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 USA tracker
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
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 (61)
| Facility | City | Region | Status |
|---|---|---|---|
| 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| Local Institution - 0017 | Aurora | Colorado | Withdrawn |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 |
| Local Institution - 0080 | Farmington | Michigan | Not Yet 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 |
| Menzies Research Institute | Hobart | Tasmania | 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 |
+ 21 more sites — see the full list on the official registry below.
More Celgene trials in the USA
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 the USA