2024-517745-14-00RecruitingPhase 2
Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, 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: EU CTIS (euclinicaltrials.eu) · Last updated 30 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 29 May 2025
- Start date
- 24 Sept 2025
- Lead sponsor
- Celgene Corp.
- Diseases
- Multiple sclerosis
- EU CT number
- 2024-517745-14-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- 22 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple sclerosis (MS) who have had spasticity (muscle stiffness) from MS for at least 6 months.
- Age
- 18-70 years old
- Sex
- All sexes can join.
- Disease stage
- MS with spasticity for at least 6 months before screening. Muscle stiffness score (modified Ashworth Scale) of 2 or more in each of 2 muscle groups, at least one in the leg (not the ankle plantar flexors). Disability score (EDSS) of 3.0-6.5.
- Earlier treatment
- People cannot join if they take a spasticity medicine that cannot be stopped and washed out by Visit 2. No cannabis, CBD or THC products in the 30 days before Visit 1.
Main reasons for not taking part
- Another disease that causes spasticity or may change spasticity
- A sudden MS relapse needing treatment, or a change in MS disease-modifying drug dose, within 3 months of Visit 1 or Visit 2
- Any history of substance abuse disorder
- Taking a spasticity medicine that cannot be stopped and washed out by Visit 2
- Cannabis, CBD or THC use within 30 days before Visit 1
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
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 (Randomization).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni Nemocnice U Sv Anny V Brne | Brno-Stred | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | Czechia | Recruiting |
| Nemocnice Pardubickeho kraje a.s. | Pardubice | Czechia | Recruiting |
| Vseobecna Fakultni Nemocnice V Praze | Prague 2 | Czechia | Recruiting |
| Fakultni Thomayerova nemocnice | Prague 4 | Czechia | Recruiting |
| Krajska zdravotni a.s. | Teplice | Czechia | Recruiting |
| Krajska Nemocnice T Bati a.s. | Zlin | Czechia | Recruiting |
| Neurozentrum Bielefeld | Bielefeld | Germany | Recruiting |
| Katholisches Klinikum Bochum gGmbH | Bochum | Germany | Recruiting |
| Technische Universitaet Dresden | Dresden | Germany | Recruiting |
| Universitaetsklinikum Jena KöR | Jena | Germany | Recruiting |
| Neurologische Gemeinschaftspraxis Kassel und Vellmar | Kassel | Germany | Recruiting |
| Universitaetsklinikum Muenster AöR | Muenster | Germany | Recruiting |
| ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen | Siegen | Germany | Recruiting |
| Klinikum Wuerzburg Mitte gGmbH | Wuerzburg | Germany | Recruiting |
| Centrum Medyczne Neuromed Sp. z.o.o. | Bydgoszcz | Poland | Recruiting |
| Pratia S.A. | Cracow | Poland | Recruiting |
| MA-LEK Clinical Sp. z o.o. | Katowice | Poland | Recruiting |
| Szpital Uniwersytecki w Krakowie | Krakowie | Poland | Recruiting |
| Miejskie Centrum Medyczne Im. Dr. Karola Jonschera W Lodzi | Lodz | Poland | Recruiting |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. | Oswiecim | Poland | Recruiting |
| NeuroProtect Sp. z o.o. | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.