NCT06782490RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
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)
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 15 Jan 2025
- Start date
- 5 Jun 2025
- Primary completion date
- 26 May 2027
- Lead sponsor
- Celgene
- Diseases
- Multiple sclerosis
- NCT number
- NCT06782490
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 5 Jun 2025 to the primary completion date, 26 May 2027
- 61 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 illness
- 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.
Other
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Recruiting |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Menzies Research Institute Coordinator of this site? Confirm its status | Hobart | Australia | Recruiting |
| Centre for Neuroscience Innovation Coordinator of this site? Confirm its status | Kent Town | Australia | Recruiting |
| Perron Institute Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| John Hunter Hospital Coordinator of this site? Confirm its status | Newcastle | Australia | Recruiting |
| The Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| University of Sydney - Brain and Mind Research Institute (BMRI) Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Centre de Recherche Saint-Louis Coordinator of this site? Confirm its status | Lévis | Canada | Recruiting |
| University Hospital - London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Montreal Neurological Institute and Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| The Ottawa Hospital - General Campus Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Unity Health Toronto, St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Fakultni nemocnice u sv. Anny v Brne Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Nemocnice Pardubickeho kraje Coordinator of this site? Confirm its status | Pardubice | Czechia | Recruiting |
| Fakultni Thomayerova nemocnice Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Prague | Czechia | Withdrawn |
| Nemocnice Teplice Coordinator of this site? Confirm its status | Teplice | Czechia | Recruiting |
| Local Institution - 0077 Coordinator of this site? Confirm its status | Zlín | Czechia | Not yet recruiting |
| Neurozentrum Bielefeld Coordinator of this site? Confirm its status | Bielefeld | Germany | Recruiting |
| St. Josef und St. Elisabeth Hospital gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Essen | Germany | Withdrawn |
| Universitätsklinikum Jena Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Neurologischen Gemeinschaftspraxis Kassel und Vellmar Coordinator of this site? Confirm its status | Kassel | Germany | Recruiting |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Meisenheim | Germany | Withdrawn |
| Universitätsklinikum Münster - Albert Schweitzer Campus Coordinator of this site? Confirm its status | Münster | Germany | Recruiting |
| Local Institution - 0078 Coordinator of this site? Confirm its status | Siegen | Germany | Not yet recruiting |
| Klinikum Würzburg Mitte Coordinator of this site? Confirm its status | Würzburg | Germany | Recruiting |
| Local Institution - 0044 Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Not yet recruiting |
| Centrum Medyczne NEUROMED Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Local Institution - 0061 Coordinator of this site? Confirm its status | Gdansk | Poland | Withdrawn |
| M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Local Institution - 0079 Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| SP ZOZ Szpital Uniwersytecki w Krakowie Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Local Institution - 0076 Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Instytut Zdrowia Dr Boczarska Jedynak Coordinator of this site? Confirm its status | Oświęcim | Poland | Recruiting |
| Local Institution - 0051 Coordinator of this site? Confirm its status | Słomniki | Poland | Withdrawn |
| Centrum Medyczne NeuroProtect Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Puerto Rico Multiple Sclerosis Center Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Recruiting |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Aurora | United States | Withdrawn |
| Alabama Neurology Associates Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| University of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Riverside Methodist Hospital Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Local Institution - 0069 Coordinator of this site? Confirm its status | Columbus | United States | Withdrawn |
| Local Institution - 0080 Coordinator of this site? Confirm its status | Farmington | United States | Not yet recruiting |
| Neurology Center of New England Coordinator of this site? Confirm its status | Foxborough | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| EvergreenHealth Medical Center Coordinator of this site? Confirm its status | Kirkland | United States | Recruiting |
| Hope Neurology Coordinator of this site? Confirm its status | Knoxville | United States | Recruiting |
| Prime Clinical Research Coordinator of this site? Confirm its status | Lewisville | United States | Recruiting |
| Aqualane Clinical Research Coordinator of this site? Confirm its status | Naples | United States | Recruiting |
| Thomas Jefferson University, Jefferson Headache Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Perseverance Research Center, LLC Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Northwest Neurology Coordinator of this site? Confirm its status | Southfield | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| USF Health Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.