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Maciejowscy S.C., Centrum Terapii SM","Katowice","40-571",{"type":55,"coordinates":732},[733,734],19.02173,50.2597,{"lat":734,"lon":733},[737],{"name":738,"role":40,"phone":739,"phoneExt":11,"email":11},"Katarzyna Maciejowska, Site 0045","665041418",{"facility":741,"status":80,"city":742,"state":11,"zip":743,"country":647,"countryCode":648,"cosmosGeoPoint":744,"geoPoint":748,"contacts":11},"Local Institution - 0051","Słomniki","32-090",{"type":55,"coordinates":745},[746,747],20.08224,50.24012,{"lat":747,"lon":746},{"facility":750,"status":48,"city":751,"state":11,"zip":752,"country":753,"countryCode":754,"cosmosGeoPoint":755,"geoPoint":759,"contacts":760},"Puerto Rico Multiple Sclerosis Center","Caguas","00725","Puerto Rico","PR",{"type":55,"coordinates":756},[757,758],-66.0485,18.23412,{"lat":758,"lon":757},[761],{"name":762,"role":40,"phone":763,"phoneExt":11,"email":11},"Jose Avila Ornelas, Site 0058","787-930-1705",{"type":765,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100576222","phase-2-a-study-to-evaluate-the-efficacy-safety-and-tolerability-of-bms-986368-in-participants-with-multiple-sclerosis-spasticity-100576222",false,"NCT06782490","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\u002FMAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1)","MSS","Inclusion Criteria\n\n* Participants must have a multiple sclerosis (MS) diagnosis.\n* Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1.\n* 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.\n* Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 at Visit 1.\n\nExclusion Criteria\n\n* Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity.\n* Participants must not have an acute MS exacerbation\u002Frelapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2.\n* 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.\n* Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2.\n* Participants must not have used FAAH\u002FMAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to Visit 1.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years","70 Years",{"count":778,"type":779},200,"ESTIMATED","INTERVENTIONAL",[782],"PHASE2","The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity",[785],"Multiple Sclerosis Spasticity",[787,788,28],"Spasticity","Multiple Sclerosis","2026-08-18",{"date":791,"type":792},"2026-08-19","ACTUAL",{"date":794,"type":792},"2025-06-05",{"date":796,"type":779},"2027-06-09",{"name":5,"class":6},55]