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Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Interferon beta-1a i.m. injections (Drug); Fingolimod oral capsules (Drug); Placebo oral capsule (Drug); Placebo i.m. injection (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: 1-888-669-6682

Summary

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

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Frequency of relapses" in patients treated for up to 24 months

Secondary outcome:

Number of new/newly enlarged T2 (n/neT2) lesions

Frequency and nature of adverse events as a measure of Safety and Tolerability

Pharmacokinetics (Cavg)of fingolimod and fingolimod-P

Eligibility

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- diagnosis of multiple sclerosis

- at least one MS relapse during the previous year or two MS relapses in the previous 2

years 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 who have detectable antibodies to interferon-beta at Screening

- 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

Locations and Contacts

Novartis Pharmaceuticals, Phone: 1-888-669-6682

Novartis Investigative Site, Vienna 1090, Austria; Recruiting

Novartis Investigative Site, Grodno 230029, Belarus; Not yet recruiting

Novartis Investigative Site, Minsk 220024, Belarus; Not yet recruiting

Novartis Investigative Site, Minsk 220114, Belarus; Not yet recruiting

Novartis Investigative Site, Vitebsk 210015, Belarus; Not yet recruiting

Novartis Investigative Site, Vitebsk 210023, Belarus; Withdrawn

Novartis Investigative Site, Belo Horizonte 30110-090, Brazil; Not yet recruiting

Novartis Investigative Site, Goiânia 74605-020, Brazil; Not yet recruiting

Novartis Investigative Site, Sofia 1612, Bulgaria; Withdrawn

Novartis Investigative Site, Sofia 1113, Bulgaria; Recruiting

Novartis Investigative Site, Praha 5 150 06, Czech Republic; Withdrawn

Novartis Investigative Site, Tallinn 10617, Estonia; Not yet recruiting

Novartis Investigative Site, Le Kremlin Bicetre 94275, France; Recruiting

Novartis Investigative Site, Marseille 13385, France; Recruiting

Novartis Investigative Site, Montpellier 34295, France; Recruiting

Novartis Investigative Site, Toulouse 31026, France; Not yet recruiting

Novartis Investigative Site, Aschaffenburg 63739, Germany; Not yet recruiting

Novartis Investigative Site, Bochum 44791, Germany; Recruiting

Novartis Investigative Site, Dresden 01307, Germany; Recruiting

Novartis Investigative Site, Erlangen 91054, Germany; Recruiting

Novartis Investigative Site, Essen 45147, Germany; Recruiting

Novartis Investigative Site, Freiburg 79106, Germany; Recruiting

Novartis Investigative Site, Goettingen 37075, Germany; Recruiting

Novartis Investigative Site, Koeln 51109, Germany; Not yet recruiting

Novartis Investigative Site, Muenchen 80337, Germany; Recruiting

Novartis Investigative Site, Tübingen 72076, Germany; Withdrawn

Novartis Investigative Site, Napoli 80131, Italy; Recruiting

Novartis Investigative Site, Riga LV-1004, Latvia; Recruiting

Novartis Investigative Site, Kaunas 50009, Lithuania; Recruiting

Novartis Investigative Site, Vilnius LT-08406, Lithuania; Withdrawn

Novartis Investigative Site, Mexico City 3310, Mexico; Not yet recruiting

Novartis Investigative Site, Rotterdam 3015 GJ, Netherlands; Recruiting

Novartis Investigative Site, Lodz 93-338, Poland; Not yet recruiting

Novartis Investigative Site, Lublin 20-093, Poland; Recruiting

Novartis Investigative Site, Poznan 60-355, Poland; Recruiting

Novartis Investigative Site, Warsaw 04-730, Poland; Withdrawn

Novartis Investigative Site, Wroclaw 50-420, Poland; Not yet recruiting

Novartis Investigative Site, Santurce 00912, Puerto Rico; Not yet recruiting

Novartis Investigative Site, Bucuresti 041914, Romania; Recruiting

Novartis Investigative Site, Kazan 420021, Russian Federation; Not yet recruiting

Novartis Investigative Site, Moscow 127018, Russian Federation; Recruiting

Novartis Investigative Site, Novosibirsk 630087, Russian Federation; Not yet recruiting

Novartis Investigative Site, St. Petersburg 197119, Russian Federation; Recruiting

Novartis Investigative Site, Belgrade 11000, Serbia; Not yet recruiting

Novartis Investigative Site, Kragujevac 34000, Serbia; Not yet recruiting

Novartis Investigative Site, Novi Sad 21000, Serbia; Not yet recruiting

Novartis Investigative Site, Durban, South Africa; Not yet recruiting

Novartis Investigative Site, Rosebank 2196, South Africa; Withdrawn

Novartis Investigative Site, Lund 221 85, Sweden; Not yet recruiting

Novartis Investigative Site, Ankara 06100, Turkey; Not yet recruiting

Novartis Investigative Site, Ankara 06500, Turkey; Not yet recruiting

Novartis Investigative Site, Atakum / Samsun 55139, Turkey; Not yet recruiting

Novartis Investigative Site, Istanbul 34093, Turkey; Not yet recruiting

Novartis Investigative Site, Istanbul 34303, Turkey; Not yet recruiting

Novartis Investigative Site, Konak/Izmir 35210, Turkey; Not yet recruiting

Novartis Investigative Site, Cherkasy 18000, Ukraine; Not yet recruiting

Novartis Investigative Site, Dnipropetrovsk 49027, Ukraine; Not yet recruiting

Novartis Investigative Site, Kharkiv 38 0561068, Ukraine; Recruiting

Novartis Investigative Site, Kharkiv 61091, Ukraine; Recruiting

Novartis Investigative Site, Kiev 03110, Ukraine; Recruiting

Novartis Investigative Site, Lviv 79010, Ukraine; Recruiting

Novartis Investigative Site, Odesa 65009, Ukraine; Recruiting

Novartis Investigative Site, Vinnytsa 21029, Ukraine; Recruiting

Novartis Investigative Site, Birmingham B4 6NH, United Kingdom; Not yet recruiting

Novartis Investigative Site, London WC1N 1EH, United Kingdom; Not yet recruiting

Novartis Investigative Site, Birmingham, Alabama 35294, United States; Recruiting

Novartis Investigative Site, Calgary, Alberta T3B 6A8, Canada; Not yet recruiting

Novartis Investigative Site, Málaga, Andalucia 29010, Spain; Recruiting

Novartis Investigative Site, Sevilla, Andalucia 41009, Spain; Recruiting

Novartis Investigative Site, Bordeaux, Aquitaine 33076, France; Recruiting

Novartis Investigative Site, Little Rock, Arkansas 72202, United States; Not yet recruiting

Novartis Investigative Site, Bari, BA 70124, Italy; Recruiting

Novartis Investigative Site, Montichiari, BS 25018, Italy; Recruiting

Novartis Investigative Site, Catania, CT 95123, Italy; Recruiting

Novartis Investigative Site, Los Angeles, California 90027, United States; Not yet recruiting

Novartis Investigative Site, San Francisco, California 94143, United States; Recruiting

Novartis Investigative Site, Barcelona, Catalunya 08035, Spain; Recruiting

Novartis Investigative Site, Aurora, Colorado 80045, United States; Recruiting

Novartis Investigative Site, Valencia, Comunidad Valenciana 46010, Spain; Recruiting

Novartis Investigative Site, North Haven, Connecticut 06473, United States; Not yet recruiting

Novartis Investigative Site, Ciudad De Mexico, D.f. 06700, Mexico; Not yet recruiting

Novartis Investigative Site, Washington, District of Columbia 20010, United States; Not yet recruiting

Novartis Investigative Site, Mexico, Distrito Federal 06720, Mexico; Recruiting

Novartis Investigative Site, México, Distrito Federal 04530, Mexico; Recruiting

Novartis Investigative Site, Vitoria, ES 29040-091, Brazil; Withdrawn

Novartis Investigative Site, Miami, Florida 33136, United States; Not yet recruiting

Novartis Investigative Site, Naples, Florida 34102, United States; Withdrawn

Novartis Investigative Site, Orlando, Florida 32819, United States; Recruiting

Novartis Investigative Site, Tallahassee, Florida 32308, United States; Recruiting

Novartis Investigative Site, West Palm Beach, Florida 33407, United States; Withdrawn

Novartis Investigative Site, Atlanta, Georgia 30322, United States; Not yet recruiting

Novartis Investigative Site, Chicago, Illinois 60611, United States; Not yet recruiting

Novartis Investigative Site, Milano, MI 20132, Italy; Recruiting

Novartis Investigative Site, Boston, Massachusetts 02114, United States; Recruiting

Novartis Investigative Site, Boston, Massachusetts 02115, United States; Not yet recruiting

Novartis Investigative Site, Detroit, Michigan 48201, United States; Recruiting

Novartis Investigative Site, New Brunswick, New Jersey 08901, United States; Not yet recruiting

Novartis Investigative Site, Buffalo, New York 14203, United States; Not yet recruiting

Novartis Investigative Site, New York, New York 10021, United States; Withdrawn

Novartis Investigative Site, Rochester, New York 14642, United States; Not yet recruiting

Novartis Investigative Site, Stony Brook, New York 11794, United States; Recruiting

Novartis Investigative Site, Syracuse, New York 13210, United States; Not yet recruiting

Novartis Investigative Site, Chapel Hill, North Carolina 27599-9500, United States; Not yet recruiting

Novartis Investigative Site, Durham, North Carolina 27710, United States; Not yet recruiting

Novartis Investigative Site, Columbus, Ohio 43205, United States; Withdrawn

Novartis Investigative Site, Ottawa, Ontario K1H 8L1, Canada; Not yet recruiting

Novartis Investigative Site, Cefalù, PA 90015, Italy; Recruiting

Novartis Investigative Site, Padova, PD 35100, Italy; Withdrawn

Novartis Investigative Site, Padova, PD 35128, Italy; Not yet recruiting

Novartis Investigative Site, Barakaldo, Pais Vasco 48903, Spain; Recruiting

Novartis Investigative Site, Philadelphia, Pennsylvania 19104-4399, United States; Not yet recruiting

Novartis Investigative Site, Rio de Janeiro, RJ 20270-004, Brazil; Not yet recruiting

Novartis Investigative Site, Roma, RM 00133, Italy; Recruiting

Novartis Investigative Site, Roma, RM 00189, Italy; Recruiting

Novartis Investigative Site, Moscow, Russia 119991, Russian Federation; Not yet recruiting

Novartis Investigative Site, Santos, SP 11015-470, Brazil; Withdrawn

Novartis Investigative Site, São Paulo, SP 05403-000, Brazil; Not yet recruiting

Novartis Investigative Site, Culiacan, Sinaloa 80020, Mexico; Withdrawn

Novartis Investigative Site, Bratislava, Slovensko 83340, Slovakia; Recruiting

Novartis Investigative Site, Greenville, South Carolina 29607, United States; Recruiting

Novartis Investigative Site, Sioux Falls, South Dakota 57104, United States; Withdrawn

Novartis Investigative Site, Dallas, Texas 75390-9034, United States; Withdrawn

Novartis Investigative Site, Fort Worth, Texas 76104, United States; Withdrawn

Novartis Investigative Site, Houston, Texas 77030, United States; Withdrawn

Novartis Investigative Site, San Antonio, Texas 78229, United States; Recruiting

Novartis Investigative Site, Salt Lake City, Utah 84108, United States; Recruiting

Novartis Investigative Site, Gallarate, VA 21013, Italy; Recruiting

Novartis Investigative Site, Parkville, Victoria 3052, Australia; Recruiting

Novartis Investigative Site, Merida, Yucatán 97125, Mexico; Withdrawn

Additional Information

Recruitment website

Starting date: July 2013
Last updated: December 9, 2014

Page last updated: August 23, 2015

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