Clinical trial NCT06782490: A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Multiple Sclerosis Spasticity
Keywords: Spasticity
Multiple Sclerosis
BMS-986368
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score
timeFrame: At week 6
Secondary outcomes:
measure: Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score
timeFrame: At week 6
measure: Change from baseline on the MS Spasticity Scale (MSSS-88) total scores
timeFrame: At week 6
measure: Change from baseline on the Timed 25-Foot Walk (T25FW) score
timeFrame: At week 6
measure: Change from baseline on the Clinical Global Impression of Severity (CGI-S) score
timeFrame: At week 6
measure: Plasma concentrations of BMS-986368 at selected pre- and post-dose time points
timeFrame: Up to week 6
measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to week 16
measure: Serious adverse events (SAEs)
timeFrame: Up to week 16
measure: Adverse events (AEs) leading to treatment discontinuation
timeFrame: Up to week 16
measure: AEs leading to death
timeFrame: Up to week 16
measure: AEs leading to clinically significant lab abnormalities
timeFrame: Up to week 16
measure: Number of participants with suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to week 16
measure: Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS)
timeFrame: Up to week 15
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Local Institution - 0050
state: Arizona
city: Aurora
country: United States
facility: Local Institution - 0017
state: Colorado
city: Tampa
country: United States
facility: Local Institution - 0015
state: Florida
city: Kansas City
country: United States
facility: Local Institution - 0016
state: Kansas
city: Foxboro
country: United States
facility: Local Institution - 0049
state: Massachusetts
city: Saint Louis
country: United States
facility: Local Institution - 0018
state: Missouri
city: Cincinnati
country: United States
facility: Local Institution - 0002
state: Ohio
city: Knoxville
country: United States
facility: Local Institution - 0003
state: Tennessee
city: Kirkland
country: United States
facility: Local Institution - 0001
state: Washington
city: Newcastle
country: Australia
facility: Local Institution - 0005
state: New South Wales
city: Sydney
country: Australia
facility: Local Institution - 0004
state: New South Wales
city: Kent Town
country: Australia
facility: Local Institution - 0030
state: South Australia
city: Box Hill
country: Australia
facility: Local Institution - 0007
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution - 0008
state: Victoria
city: Parkville
country: Australia
facility: Local Institution - 0006
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution - 0019
state: Western Australia
city: Edmonton
country: Canada
facility: Local Institution - 0013
state: Alberta
city: London
country: Canada
facility: Local Institution - 0024
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution - 0012
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0028
state: Ontario
city: Lévis
country: Canada
facility: Local Institution - 0014
state: Quebec
city: Montreal
country: Canada
facility: Local Institution - 0029
state: Quebec
city: Brno
country: Czechia
facility: Local Institution - 0055
state: Brno-město
city: Hradec Kralove
country: Czechia
facility: Local Institution - 0010
state: Hradec Králové
city: Prague
country: Czechia
facility: Local Institution - 0054
state: Praha 2
city: Prague
country: Czechia
facility: Local Institution - 0059
state: Praha 4
city: Praha
country: Czechia
facility: Local Institution - 0011
state: Praha 5
city: Pardubice
country: Czechia
facility: Local Institution - 0053
city: Teplice
country: Czechia
facility: Local Institution - 0009
state: Ústecký Kraj
city: Wuerzburg
country: Germany
facility: Local Institution - 0052
state: Bayern
city: Kassel
country: Germany
facility: Local Institution - 0022
state: Hessen
city: Bochum
country: Germany
facility: Local Institution - 0027
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Local Institution - 0060
state: Nordrhein-Westfalen
city: Meisenheim
country: Germany
facility: Local Institution - 0031
state: Rheinland-Pfalz
city: Jena
country: Germany
facility: Local Institution - 0023
state: Thüringen
city: Bielefeld
country: Germany
facility: Local Institution - 0051
city: Dresden
country: Germany
facility: Local Institution - 0021
city: Essen
country: Germany
facility: Local Institution - 0020
city: Bydgoszcz
country: Poland
facility: Local Institution - 0057
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Local Institution - 0044
state: Kujawsko-pomorskie
city: Oswiecim
country: Poland
facility: Local Institution - 0048
state: MA
city: Kraków
country: Poland
facility: Local Institution - 0046
state: Małopolskie
city: Kraków
country: Poland
facility: Local Institution - 0056
state: Małopolskie
city: Warszawa
country: Poland
facility: Local Institution - 0047
state: MZ
city: Gdańsk
country: Poland
facility: Local Institution - 0061
city: Slomniki
country: Poland
facility: Local Institution - 0051
city: Katowice
country: Poland
facility: Local Institution - 0045
state: Śląskie
city: Caguas
country: Puerto Rico
facility: Local Institution - 0058
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: