Clinical Trials in Poland / 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 Poland 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 (58)
| 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| Local Institution - 0017 | Aurora | Colorado | Withdrawn |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 |
| 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.
More Celgene trials in Poland
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Active, not recruiting
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