Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants with Multiple Sclerosis Spasticity
Key facts
- Where
- Bielefeld, Bochum, Dresden, Jena, Kassel, Muenster, Siegen és Wuerzburg, NémetországSee the 8 sites
- Phase
- 2. fázis
Where in Németország
- Neurozentrum BielefeldBielefeld, NémetországTaking people
- Katholisches Klinikum Bochum gGmbHBochum, NémetországTaking people
- Technische Universitaet DresdenDresden, NémetországTaking people
- Universitaetsklinikum Jena KöRJena, NémetországTaking people
- Neurologische Gemeinschaftspraxis Kassel und VellmarKassel, NémetországTaking people
- Universitaetsklinikum Muenster AöRMuenster, NémetországTaking people
- ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung SiegenSiegen, NémetországTaking people
- Klinikum Wuerzburg Mitte gGmbHWuerzburg, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Celgene Corp.
- Trial code
- EU 2024-517745-14-00
- Record updated
- 2026. október 30.
- Original description
The main goal (objective) of the study is to understand the effect of BMS-986368 compared with placebo (a pill with no medicine), on spasticity in patients with MS.Read full original descriptionShow less
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)
The main goal (objective) of the study is to understand the effect of BMS-986368 compared with placebo (a pill with no medicine), on spasticity in patients with MS.
Inclusion: Participants must be 18-70 years old who 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 (Screening); 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 (meaning moderate-significant disability) at Visit 1.
Exclusion: Participants must not have had any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant’s level of spasticity; Participants must not have a history of any substance abuse disorder. 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 cannabinoid-related products (including cannabis, CBD, or THC) within 30 days prior to Visit 1. Other protocol defined Inclusion/Exclusion criteria apply; 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 (Randomization).