A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Local Institution - 0114
NOT_YET_RECRUITING
Loma Linda
Local Institution - 0130
NOT_YET_RECRUITING
Sacramento
Florida
University of South Florida
RECRUITING
Tampa
Illinois
Local Institution - 0055
NOT_YET_RECRUITING
Chicago
Local Institution - 0093
WITHDRAWN
Chicago
Kentucky
Local Institution - 0047
NOT_YET_RECRUITING
Louisville
New Jersey
Local Institution - 0131
NOT_YET_RECRUITING
New Brunswick
Local Institution - 0132
WITHDRAWN
Teaneck
Ohio
Local Institution - 0091
WITHDRAWN
Cincinnati
Oregon
Local Institution - 0092
NOT_YET_RECRUITING
Portland
Texas
Local Institution - 0133
NOT_YET_RECRUITING
El Paso
Wisconsin
Local Institution - 0033
NOT_YET_RECRUITING
Milwaukee
Other Locations
Australia
Royal Children's Hospital
RECRUITING
Melbourne
Italy
Local Institution - 0081
NOT_YET_RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
University of Naples Federico II
RECRUITING
Napoli
Neurological Center Of Latium
RECRUITING
Rome
Mexico
Local Institution - 0078
WITHDRAWN
Mexico City
Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Portugal
2Ca Braga
RECRUITING
Braga
Unidade Local de Saúde de Coimbra, E.P.E.
RECRUITING
Coimbra
Centro Hospitalar de Lisboa Central
RECRUITING
Lisbon
Local Institution - 0102
WITHDRAWN
Porto
Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING
Bucharest
Spitalul Clinic de Copii Doctor Victor Gomoiu
RECRUITING
Bucharest
Spain
Local Institution - 0096
NOT_YET_RECRUITING
Esplugues De Llobregat
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
CHUVI- Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Turkey
Ondokuz Mayıs Universitesi
RECRUITING
Samsun
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.