Recruiting
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity - IM045-1018
Atualizado: 11 novembro, 2025 | ClinicalTrials.gov
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Recruiting
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. - 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.
É altamente recomendável que você entre em contato com a BMS para relatar efeitos colaterais (eventos adversos).
Efeitos colaterais (eventos adversos) e outros eventos relatáveis estão definidos aqui.
Relate efeitos colaterais (eventos adversos) ou reclamações sobre a qualidade do produto: Informações médicas
