A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Recruiting · NCT06782490 · Interventional (participants receive a specific treatment) · Lead sponsor: Celgene
View the official record on ClinicalTrials.gov →Interventions studied
BMS-986368Placebo
What this trial is about
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
55 locations listed across 13 US states.
- Alabama Neurology Associates - Birmingham, Alabama, United States
- Perseverance Research Center,LLC - Scottsdale, Arizona, United States
- Local Institution - 0017 - Aurora, Colorado, United States
- Aqualane Clinical Research - Naples, Florida, United States
- USF Health - Tampa, Florida, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Neurology Center of New England - Foxborough, Massachusetts, United States
- Northwest Neurology - Southfield, Michigan, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States
- Riverside Methodist Hospital - Columbus, Ohio, United States
- Local Institution - 0069 - Columbus, Ohio, United States
- Thomas Jefferson University, Jefferson Headache Center - Philadelphia, Pennsylvania, United States
- Hope Neurology - Knoxville, Tennessee, United States
- Local Institution - 0072 - Lewisville, Texas, United States
- EvergreenHealth Medical Center - Kirkland, Washington, United States
- Neurozentrum Bielefeld - Bielefeld, Germany
- Puerto Rico Multiple Sclerosis Center - Caguas, Puerto Rico
- Universitaetsklinikum Carl Gustav Carus Dresden - Dresden, Germany
- Local Institution - 0020 - Essen, Germany
- Local Institution - 0061 - Gdansk, Poland
- M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM - Katowice, Poland
- Nemocnice Pardubického kraje - Pardubice, Czechia
- Local Institution - 0051 - Słomniki, Poland
- University Of Alberta Hospital - Edmonton, Alberta, Canada
- Klinikum Würzburg Mitte - Würzburg, Bavaria, Germany
- Fakultni Nemocnice u sv. Anny v Brne - Brno, Brno-město, Czechia
- Neurologischen Gemeinschaftspraxis Kassel und Vellmar - Kassel, Hesse, Germany
- Fakultni nemocnice Hradec Kralove - Hradec Králové, Hradec Králové, Czechia
- Centrum Medyczne NEUROMED - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Local Institution - 0044 - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Pratia MCM Krakow - Krakow, Lesser Poland Voivodeship, Poland
- SP ZOZ Szpital Uniwersytecki w Krakowie - Krakow, Lesser Poland Voivodeship, Poland
- Instytut Zdrowia Dr Boczarska Jedynak - Oświęcim, Lesser Poland Voivodeship, Poland
- Centrum Medyczne NeuroProtect - Warsaw, Masovian Voivodeship, Poland
- John Hunter Hospital - Newcastle, New South Wales, Australia
- University of Sydney - Brain and Mind Research Institute (BMRI) - Sydney, New South Wales, Australia
- St. Josef und St. Elisabeth Hospital gGmbH - Bochum, North Rhine-Westphalia, Germany
- Universitätsklinikum Münster - Albert Schweitzer Campus - Münster, North Rhine-Westphalia, Germany
- University Hospital - London Health Sciences Centre - London, Ontario, Canada
- The Ottawa Hospital - General Campus - Ottawa, Ontario, Canada
- Unity Health Toronto, St. Michael's Hospital - Toronto, Ontario, Canada
- Vseobecna fakultni nemocnice v Praze - Prague, Praha 2, Czechia
- Fakultni Thomayerova nemocnice - Prague, Praha 4, Czechia
- Local Institution - 0011 - Prague, Praha 5, Czechia
- Centre de Recherche Saint-Louis - Lévis, Quebec, Canada
- Montreal Neurological Institute and Hospital - Montreal, Quebec, Canada
- Local Institution - 0031 - Meisenheim, Rhineland-Palatinate, Germany
- Centre for Neuroscience Innovation - Kent Town, South Australia, Australia
- Universitätsklinikum Jena - Jena, Thuringia, Germany
- Box Hill Hospital - Box Hill, Victoria, Australia
- Austin Health - Heidelberg, Victoria, Australia
- The Royal Melbourne Hospital - Parkville, Victoria, Australia
- Perron Institute - Nedlands, Western Australia, Australia
- Nemocnice Teplice - Teplice, Ústí nad Labem Region, Czechia