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Taking people in GermanyPhase 2

Tests BMS-986368 for muscle stiffness in people with multiple sclerosis

Compares a new pill, BMS-986368, with a placebo for muscle stiffness in adults with MS.

Key facts

Who runs it
Celgene Corp.
Where
Bielefeld, Bochum, Dresden, Jena, Kassel, Muenster, Siegen, and Wuerzburg, GermanySee the 8 sitesAlso in 2 other countries, 14 sites
Trial code
Registry title
Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants with Multiple Sclerosis Spasticity
Status
Recruiting
Phase
Phase 2
People taking part
100 people, planned
Started
24 Sept 2025
Expected to end
3 May 2027
Type of study
Interventional
Record updated
30 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Germany

Also in 2 other countries, 14 sites

  • Neurozentrum BielefeldBielefeld, GermanyTaking people
  • Katholisches Klinikum Bochum gGmbHBochum, GermanyTaking people
  • Technische Universitaet DresdenDresden, GermanyTaking people
  • Universitaetsklinikum Jena KöRJena, GermanyTaking people
  • Neurologische Gemeinschaftspraxis Kassel und VellmarKassel, GermanyTaking people
  • Universitaetsklinikum Muenster AöRMuenster, GermanyTaking people
  • ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung SiegenSiegen, GermanyTaking people
  • Klinikum Wuerzburg Mitte gGmbHWuerzburg, GermanyTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Tests BMS-986368 for muscle stiffness in people with multiple sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
30 October 2026