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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06782490




Registration number
NCT06782490
Ethics application status
Date submitted
15/01/2025
Date registered
20/01/2025

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Scientific 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/MGLL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1)
Secondary ID [1] 0 0
IM045-1018
Universal Trial Number (UTN)
Trial acronym
MSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis Spasticity 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986368
Treatment: Drugs - Placebo

Experimental: Administration of BMS-986368 Dose A -

Experimental: Administration of BMS-986368 Dose B -

Experimental: Administration of BMS-986368 Dose C -

Placebo comparator: Placebo -


Treatment: Drugs: BMS-986368
Specified dose on specified days

Treatment: Drugs: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score
Timepoint [1] 0 0
At week 6
Secondary outcome [1] 0 0
Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score
Timepoint [1] 0 0
At week 6
Secondary outcome [2] 0 0
Change from baseline on the MS Spasticity Scale (MSSS-88) total scores
Timepoint [2] 0 0
At week 6
Secondary outcome [3] 0 0
Change from baseline on the Timed 25-Foot Walk (T25FW) score
Timepoint [3] 0 0
At week 6
Secondary outcome [4] 0 0
Clinical Global Impression of Change (CGI-C) score
Timepoint [4] 0 0
At week 6
Secondary outcome [5] 0 0
Plasma concentrations of BMS-986368 at selected pre- and post-dose time points
Timepoint [5] 0 0
Up to week 6
Secondary outcome [6] 0 0
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Timepoint [6] 0 0
Up to week 16
Secondary outcome [7] 0 0
Serious adverse events (SAEs)
Timepoint [7] 0 0
Up to week 16
Secondary outcome [8] 0 0
Adverse events (AEs) leading to treatment discontinuation
Timepoint [8] 0 0
Up to week 16
Secondary outcome [9] 0 0
AEs leading to death
Timepoint [9] 0 0
Up to week 16
Secondary outcome [10] 0 0
AEs leading to clinically significant lab abnormalities
Timepoint [10] 0 0
Up to week 16
Secondary outcome [11] 0 0
Number of participants with suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Timepoint [11] 0 0
Up to week 16
Secondary outcome [12] 0 0
Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS)
Timepoint [12] 0 0
Up to week 15

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.
* 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, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to Visit 1.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
14/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/11/2026
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0005 - Newcastle
Recruitment hospital [2] 0 0
Local Institution - 0004 - Sydney
Recruitment hospital [3] 0 0
Local Institution - 0030 - Kent Town
Recruitment hospital [4] 0 0
Local Institution - 0007 - Box Hill
Recruitment hospital [5] 0 0
Local Institution - 0008 - Heidelberg
Recruitment hospital [6] 0 0
Local Institution - 0006 - Parkville
Recruitment hospital [7] 0 0
Local Institution - 0019 - Nedlands
Recruitment postcode(s) [1] 0 0
2305 - Newcastle
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
5067 - Kent Town
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Czechia
State/province [13] 0 0
Brno-mesto
Country [14] 0 0
Czechia
State/province [14] 0 0
Hradec Králové
Country [15] 0 0
Czechia
State/province [15] 0 0
Praha 2
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha 4
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha 5
Country [18] 0 0
Czechia
State/province [18] 0 0
Pardubice
Country [19] 0 0
Czechia
State/province [19] 0 0
Ústecký Kraj
Country [20] 0 0
Germany
State/province [20] 0 0
Bayern
Country [21] 0 0
Germany
State/province [21] 0 0
Hessen
Country [22] 0 0
Germany
State/province [22] 0 0
Nordrhein-Westfalen
Country [23] 0 0
Germany
State/province [23] 0 0
Rheinland-Pfalz
Country [24] 0 0
Germany
State/province [24] 0 0
Thüringen
Country [25] 0 0
Germany
State/province [25] 0 0
Bielefeld
Country [26] 0 0
Germany
State/province [26] 0 0
Dresden
Country [27] 0 0
Germany
State/province [27] 0 0
Essen
Country [28] 0 0
Poland
State/province [28] 0 0
Kujawsko-pomorskie
Country [29] 0 0
Poland
State/province [29] 0 0
Malopolskie
Country [30] 0 0
Poland
State/province [30] 0 0
Gdansk
Country [31] 0 0
Poland
State/province [31] 0 0
Slaskie
Country [32] 0 0
Puerto Rico
State/province [32] 0 0
Caguas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See plan description
Available to whom?
See plan description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06782490