Clinical Trial Details

NCT ID: NCT01892722
Date Last Changed: November 10, 2016

Overview

Research Study Summary

A clinical trial to evaluate treatments using Interferon beta-1a i.m. injections, Fingolimod oral capsules, Placebo oral capsule and Placebo i.m. injection for patients with Multiple Sclerosis

Research Study Title

Two-year, Double-blind, Randomzied, Multicenter, Active-controlled Study to Evaluate Safety and Efficacy of Oral Fingolimod Versus Interferon Beta-1a i.m. in Pediatric Patients With Multiple Sclerosis

Purpose

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pedaitric patients with multiple sclerosis

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
10 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Novartis Pharmaceuticals
Duration
116 Months
Facility Type
N/A
Compensation

Eligibility

All ages 10 Years to 17 Years

Inclusion Criteria:

  • diagnosis of multiple sclerosis

  • at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive

Exclusion Criteria:

  • patients with progressive MS

  • patients with an active, chronic disease of the immune system other than MS

  • patients meeting the definition of ADEM

  • patients with severe cardiac disease or significant findings on the screening ECG.

  • patients with severe renal insufficiency Other protocol-defined inclusion/exclusion criteria may apply

Site Locations (59)

Country State City Zip Facility and Contact
United States California San Francisco 94143 Novartis Investigative Site
United States Florida Tallahassee 32308 Novartis Investigative Site
United States Massachusetts Boston 02114 Novartis Investigative Site
United States Michigan Detroit 48201 Novartis Investigative Site
United States New Jersey New Brunswick 08901 Novartis Investigative Site
United States Pennsylvania Philadelphia 19104-4399 Novartis Investigative Site
United States Utah Salt Lake City 84108 Novartis Investigative Site
Australia Victoria Parkville 3052 Novartis Investigative Site
Austria Vienna 1090 Novartis Investigative Site
Belarus Minsk 220114 Novartis Investigative Site
Brazil Minas Gerais Belo Horizonte 30150-221 Novartis Investigative Site
Bulgaria Sofia 1113 Novartis Investigative Site
Canada Alberta Calgary T3B 6A8 Novartis Investigative Site
Canada Ontario Ottawa K1H 8L1 Novartis Investigative Site
France Le Kremlin Bicetre 94275 Novartis Investigative Site
France Marseille 13385 Novartis Investigative Site
France Montpellier 34295 Novartis Investigative Site
France Toulouse 31059 Novartis Investigative Site
Germany Bochum 44791 Novartis Investigative Site
Germany Bonn 53111 Novartis Investigative Site
Germany Erlangen 91054 Novartis Investigative Site
Germany Freiburg 79106 Novartis Investigative Site
Germany Goettingen 37075 Novartis Investigative Site
Germany Muenchen 80337 Novartis Investigative Site
Germany Muenster 48149 Novartis Investigative Site
Italy BS Montichiari 25018 Novartis Investigative Site
Italy MI Milano 20132 Novartis Investigative Site
Italy Napoli 80131 Novartis Investigative Site
Latvia Riga LV-1004 Novartis Investigative Site
Mexico D.f. Ciudad De Mexico 06700 Novartis Investigative Site
Mexico Distrito Federal Mexico 03310 Novartis Investigative Site
Mexico Distrito Federal Mexico 06720 Novartis Investigative Site
Netherlands Rotterdam 3015 GJ Novartis Investigative Site
Poland Poznan 60-355 Novartis Investigative Site
Poland Wroclaw 50-420 Novartis Investigative Site
Puerto Rico Santurce 00912 Novartis Investigative Site
Romania Bucuresti 041914 Novartis Investigative Site
Serbia Belgrade 11000 Novartis Investigative Site
Serbia Kragujevac 34000 Novartis Investigative Site
Serbia Novi Sad 21000 Novartis Investigative Site
Spain Andalucia Malaga 29010 Novartis Investigative Site
Spain Andalucia Sevilla 41009 Novartis Investigative Site
Spain Pais Vasco Barakaldo 48903 Novartis Investigative Site
Turkey Ankara 06100 Novartis Investigative Site
Turkey Ankara 06500 Novartis Investigative Site
Turkey Atakum / Samsun 55139 Novartis Investigative Site
Turkey Balcova / Izmir 35340 Novartis Investigative Site
Turkey Konak/Izmir 35210 Novartis Investigative Site
Ukraine Cherkasy 18000 Novartis Investigative Site
Ukraine Dnipropetrovsk 49027 Novartis Investigative Site
Ukraine Kharkiv 61068 Novartis Investigative Site
Ukraine Kharkiv 61091 Novartis Investigative Site
Ukraine Kiev 03110 Novartis Investigative Site
Ukraine Lviv 79010 Novartis Investigative Site
Ukraine Odesa 65009 Novartis Investigative Site
Ukraine Vinnytsa 21029 Novartis Investigative Site
United Kingdom Birmingham West Midlands B4 6NH Novartis Investigative Site
United Kingdom Edinburgh Novartis Investigative Site
United Kingdom London WC1N 1EH Novartis Investigative Site

Contact

Novartis Pharmaceuticals
1-888-669-6682

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