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Набира участници Фаза 3 NCT06408259

Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Multiple Sclerosis, Relapsing-Remitting

Спонсор: Celgene

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).
Кой може да участва
Inclusion Criteria: * Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease. * Meets at least 1 of the following criteria for disease activity: i) At least 1 MS relapse/attack in the previous year prior to screening. ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening. iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI). \- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive. Exclusion Criteria: * Diagnosis of progressive forms of MS. * Active or chronic disease of the immune system other than MS. * Clinically relevant cardiovascular, hepatic, neurological other major systematic disease. * Other protocol-defined Inclusion/Exclusion criteria apply.
Места на провеждане 10
Австралия (1)
Royal Children's Hospital
Melbourne , Victoria
Eppie Yiu, Site 0113
Италия (1)
University of Naples Federico II
Naples , Campania
Vincenzo Brescia Morra, Site 0083
Mexico (1)
Local Institution - 0078
Mexico City , DIF
WITHDRAWN
Полша (1)
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan , Greater Poland Voivodeship
Barbara Steinborn, Site 0108
Puerto Rico (1)
Local Institution - 0134
Caguas
NOT_YET_RECRUITING
Румъния (1)
Spitalul Clinic de Copii Doctor Victor Gomoiu
Bucharest , Bucharest
Raluca Teleanu, Site 0088
Испания (1)
Local Institution - 0096
Esplugues de Llobregat , Barcelona [Barcelona]
NOT_YET_RECRUITING
Taiwan (1)
National Taiwan University Hospital
Taipei
Wang-Tso Lee, Site 0115
Турция (1)
Ondokuz Mayıs Universitesi
Samsun
murat terzi, Site 0109
САЩ (1)
Local Institution - 0114
Loma Linda , California
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
10 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
08.04.2025
Крайна дата
13.07.2036
Регистрационен номер
NCT06408259
Източник
anzctr
Запитване за медицински туризъм

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