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  • NCT06782490

Recruiting

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity - IM045-1018

Uppdaterad: 11 november, 2025   |   ClinicalTrials.gov

Celgene är ett helägt dotterbolag till Bristol-Myers Squibb 

Utskriftsvänlig sammanfattning

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Använd broschyren ”Om att delta i en klinisk prövning” för att få vägledning om deltagandeprocessen i en klinisk prövning. Förstå de viktiga faktorerna som man måste tänka på före ett beslut och få hjälp med att formulera frågor till studiepersonalen.
Skriv ut den här sidan IM045-1018
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VÄLJ SPRÅK

Information om prövningen

  • Phase 2

    Fas

  • Kön

  • 18-70

    Åldersintervall

  • 47

    Platser

  • Recruiting

Behandlingsalternativ

Studiegrupper
TILLDELAD BEHANDLING
Experimental: Administration of BMS-986368 Dose A
Drug: BMS-986368
Experimental: Administration of BMS-986368 Dose B
Drug: BMS-986368
Experimental: Administration of BMS-986368 Dose C
Drug: BMS-986368
Placebo Comparator: Placebo
Drug: Placebo

Viktiga kriterier för deltagandet

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.

Vi rekommenderar att du kontaktar BMS för att rapportera biverkningar.
Biverkningar (oönskade händelser) och andra rapporterbara händelser definieras här
För att rapportera biverkningar (oönskade händelser) eller reklamera ett läkemedel: Medicinsk information

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