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Набира участници Фаза 2 NCT06782490

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Multiple Sclerosis Spasticity

Спонсор: Celgene

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity
Кой може да участва
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.
Места на провеждане 7
Австралия (1)
John Hunter Hospital
Newcastle , New South Wales
Jeannette Lechner-Scott, Site 0005
Канада (1)
University Of Alberta Hospital
Edmonton , Alberta
Gregg Blevins, Site 0013
Чехия (1)
Fakultni Nemocnice u sv. Anny v Brne
Brno , Brno-město
Martin Pail, Site 0055
Германия (1)
Klinikum Würzburg Mitte
Würzburg , Bavaria
Mathias Mäurer, Site 0052
Полша (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
САЩ (1)
Local Institution - 0033
Birmingham , Alabama
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
05.06.2025
Крайна дата
09.06.2027
Регистрационен номер
NCT06782490
Източник
anzctr
Запитване за медицински туризъм

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