Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

July 26, 2013

Primary Completion Date

July 14, 2017

Study Completion Date

February 18, 2030

Conditions
Multiple Sclerosis
Interventions
DRUG

Interferon beta-1a

Administration once weekly via i.m. injections.

DRUG

Fingolimod

"Administrated orally once daily:~0.5 mg capsule for patients over 40 kg or 0.25 mg capsule for patients 40 kg or less."

DRUG

Placebo capsule

Matching placebo capsule required for double-dummy masking to blind formulations.

DRUG

Placebo i.m. injection

Matching placebo i.m. injection required for double-dummy masking to blind formulations.

Trial Locations (73)

1090

Novartis Investigative Site, Vienna

1113

Novartis Investigative Site, Sofia

3052

Novartis Investigative Site, Parkville

10617

Novartis Investigative Site, Tallinn

11000

Novartis Investigative Site, Belgrade

13885

Novartis Investigative Site, Marseille

20132

Novartis Investigative Site, Milan

21013

Novartis Investigative Site, Gallarate

25018

Novartis Investigative Site, Montichiari

28006

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

31000

Novartis Investigative Site, Osijek

31059

Novartis Investigative Site, Toulouse

32312

AMO Corporation, Tallahassee

33076

Novartis Investigative Site, Bordeaux

33136

University of Miami, Miami

34090

Novartis Investigative Site, Montpellier

34098

Novartis Investigative Site, Istanbul

35294

UAB Childrens Hospital Harbor Center Neurology Dept, Birmingham

35340

Novartis Investigative Site, Izmir

36212

Novartis Investigative Site, Vigo

37075

Novartis Investigative Site, Göttingen

41009

Novartis Investigative Site, Seville

44791

Novartis Investigative Site, Bochum

46010

Novartis Investigative Site, Valencia

48201

Wayne State University, Detroit

48903

Novartis Investigative Site, Barakaldo

55200

Novartis Investigative Site, Samsun

61068

Novartis Investigative Site, Kharkiv

70124

Novartis Investigative Site, Bari

79106

Novartis Investigative Site, Freiburg im Breisgau

84108

University of Utah Clinical Trials Office, Salt Lake City

90015

Novartis Investigative Site, Cefalù

90027

Childrens Hospital Los Angeles, Los Angeles

91054

Novartis Investigative Site, Erlangen

94115

UCSF, San Francisco

94275

Novartis Investigative Site, Le Kremlin-Bicêtre

95123

Novartis Investigative Site, Catania

119602

Novartis Investigative Site, Moscow

119991

Novartis Investigative Site, Moscow

197110

Novartis Investigative Site, Saint Petersburg

420043

Novartis Investigative Site, Kazan'

630087

Novartis Investigative Site, Novosibirsk

02114

Massachusetts General Hospital, Boston

08901

Robert Wood Johnson Medical School, New Brunswick

19104 4399

Childrens Hospital of Philadelphia, Philadelphia

30150 221

Novartis Investigative Site, Belo Horizonte

20270-004

Novartis Investigative Site, Rio de Janeiro

05403-000

Novartis Investigative Site, São Paulo

74605 020

Novartis Investigative Site, Goiânia

T3B 6A8

Novartis Investigative Site, Calgary

K1H 8L6

Novartis Investigative Site, Ottawa

01307

Novartis Investigative Site, Dresden

00133

Novartis Investigative Site, Roma

00189

Novartis Investigative Site, Roma

LV-1004

Novartis Investigative Site, Riga

LT 50161

Novartis Investigative Site, Kaunas

06700

Novartis Investigative Site, Mexico City

03310

Novartis Investigative Site, Distrito Federal

3015 CN

Novartis Investigative Site, Rotterdam

93-338

Novartis Investigative Site, Lodz

20-093

Novartis Investigative Site, Lublin

60-355

Novartis Investigative Site, Poznan

54-049

Novartis Investigative Site, Wroclaw

00912

San Jorge Childrens Hospital, Santurce

041914

Novartis Investigative Site, Bucharest

833 40

Novartis Investigative Site, Bratislava

06230

Novartis Investigative Site, Ankara

06500

Novartis Investigative Site, Ankara

B4 6NH

Novartis Investigative Site, West Midlands

EH9 1LF

Novartis Investigative Site, Edinburgh

NW1 2BU

Novartis Investigative Site, London

WC1N 3JH

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY