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Recruiting Phase 2 NCT06782490

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity

Phase 2 – studying effectiveness and dosage
Conditions: Multiple Sclerosis Spasticity

Sponsor: Celgene

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
Who can participate
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.
Locations 7
Australia (1)
John Hunter Hospital
Newcastle , New South Wales
Jeannette Lechner-Scott, Site 0005
Canada (1)
University Of Alberta Hospital
Edmonton , Alberta
Gregg Blevins, Site 0013
Czech Republic (1)
Fakultni Nemocnice u sv. Anny v Brne
Brno , Brno-město
Martin Pail, Site 0055
Germany (1)
Klinikum Würzburg Mitte
Würzburg , Bavaria
Mathias Mäurer, Site 0052
Poland (1)
Centrum Medyczne NEUROMED
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Pawel Lisewski, Site 0057
Puerto Rico (1)
Puerto Rico Multiple Sclerosis Center
Caguas
Jose Avila Ornelas, Site 0058
United States (1)
Local Institution - 0033
Birmingham , Alabama
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
05.06.2025
Completion date
09.06.2027
Registry ID
NCT06782490
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.