Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase

ClinicalTrials.gov Identifier: NCT01892722

Novartis Reference Number: CFTY720D2311

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Multiple Sclerosis
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
245 participants
Start date 
Jul 26, 2013
Completion date 
Dec 15, 2028
Gender 
All
Age(s)
10 Years - 17 Years (Child)

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.

Eligibility Criteria

Key Inclusion Criteria Core Phase:

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

Key Exclusion Criteria Core Phase:

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

Key Inclusion Criteria Extension Phase:

Applies to all patients participating in the Core Phase and then entering the Extension Phase. 1. Patients that originally met Core Phase Inclusion criteria and completed the Core phase on or off of study drug.

Applies to patients newly recruited to participate in the Extension Phase.

All newly recruited patients' that enroll directly into the Extension Phase must fulfill the local country health authority product label approved for pediatric age group for inclusion criteria.
Central review (including initial MRI report) of the diagnosis of pediatric MS will be required for all newly recruited patients.

Key Exclusion Criteria Extension Phase:

Applies to patients who completed the Core Phase, but prematurely discontinued study drug.

Premature discontinuation of the study drug during the Core Phase due to:

an adverse event,
serious adverse event,
laboratory abnormality
other conditions leading to permanent study drug discontinuation due to safety reasons
Patients with known new events or concomitant medications (washout periods required prior to Visit 15) that would exclude them from the Core Phase exclusion criteria. Serological or other additional tests will not be required.

Applies to patients newly recruited in the younger cohort to participate in the Extension Phase.

1. All newly recruited patients in the younger cohort that enroll directly into the Extension Phase must fulfill the exclusion criteria for the core phase.

Study Locations

United States
Novartis Investigative Site
Active, not recruiting
Birmingham, 35294
Alabama
United States
Novartis Investigative Site
Withdrawn
Little Rock, 72202
Arkansas
United States
Novartis Investigative Site
Active, not recruiting
Los Angeles, 90027
California
United States
Novartis Investigative Site
Completed
San Francisco, 94143
California
United States
Novartis Investigative Site
Withdrawn
Aurora, 80045
Colorado
United States
Novartis Investigative Site
Active, not recruiting
Miami, 33136
Florida
United States
Novartis Investigative Site
Terminated
Orlando, 32819
Florida
United States
Novartis Investigative Site
Active, not recruiting
Tallahassee, 32308
Florida
United States
Novartis Investigative Site
Withdrawn
Chicago, 60611
Illinois
United States
Novartis Investigative Site
Active, not recruiting
Boston, 02114
Massachusetts
United States
Novartis Investigative Site
Withdrawn
Boston, 02115
Massachusetts
United States
Novartis Investigative Site
Active, not recruiting
Detroit, 48201
Michigan
United States
Novartis Investigative Site
Active, not recruiting
New Brunswick, 08901
New Jersey
United States
Novartis Investigative Site
Withdrawn
Rochester, 14642
New York
United States
Novartis Investigative Site
Withdrawn
Stony Brook, 11794
New York
United States
Novartis Investigative Site
Withdrawn
Chapel Hill, 27599-9500
North Carolina
United States
Novartis Investigative Site
Withdrawn
Durham, 27710
North Carolina
United States
Novartis Investigative Site
Completed
Philadelphia, 19104 4399
Pennsylvania
United States
Novartis Investigative Site
Withdrawn
Greenville, 29607
South Carolina
United States
Novartis Investigative Site
Withdrawn
San Antonio, 78229
Texas
United States
Novartis Investigative Site
Active, not recruiting
Salt Lake City, 84108
Utah
United States
Australia
Novartis Investigative Site
Recruiting
Parkville, 3052
Victoria
Australia
Austria
Novartis Investigative Site
Recruiting
Vienna, 1090
-
Austria
Belarus
Novartis Investigative Site
Recruiting
Minsk, 220114
-
Belarus
Brazil
Novartis Investigative Site
Active, not recruiting
Belo Horizonte, 30150 221
Minas Gerais
Brazil
Novartis Investigative Site
Active, not recruiting
Rio de Janeiro, 20270-004
RJ
Brazil
Novartis Investigative Site
Completed
Sao Paulo, 05403-000
SP
Brazil
Novartis Investigative Site
Active, not recruiting
Goiania, 74605 020
-
Brazil
Bulgaria
Novartis Investigative Site
Active, not recruiting
Sofia, 1113
-
Bulgaria
Canada
Novartis Investigative Site
Active, not recruiting
Calgary, T3B 6A8
Alberta
Canada
Novartis Investigative Site
Completed
Ottawa, K1H 8L1
Ontario
Canada
Croatia
Novartis Investigative Site
Completed
Osijek, 31000
-
Croatia
Estonia
Novartis Investigative Site
Terminated
Tallinn, 10617
-
Estonia
France
Novartis Investigative Site
Completed
Bordeaux Cedex, F-33076
-
France
Novartis Investigative Site
Recruiting
Le Kremlin Bicetre, 94275
-
France
Novartis Investigative Site
Completed
Marseille, 13385
-
France
Novartis Investigative Site
Active, not recruiting
Montpellier, 34295
-
France
Novartis Investigative Site
Completed
Toulouse Cedex, 31059
-
France
Germany
Novartis Investigative Site
Active, not recruiting
Bochum, 44791
-
Germany
Novartis Investigative Site
Withdrawn
Bonn, 53111
-
Germany
Novartis Investigative Site
Active, not recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Active, not recruiting
Erlangen, 91054
-
Germany
Novartis Investigative Site
Withdrawn
Essen, 45147
-
Germany
Novartis Investigative Site
Active, not recruiting
Freiburg, 79106
-
Germany
Novartis Investigative Site
Active, not recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Withdrawn
Hamburg, 20246
-
Germany
Novartis Investigative Site
Terminated
Muenchen, 80337
-
Germany
Novartis Investigative Site
Withdrawn
Muenster, 48149
-
Germany
Italy
Novartis Investigative Site
Terminated
Bari, 70124
BA
Italy
Novartis Investigative Site
Active, not recruiting
Montichiari, 25018
BS
Italy
Novartis Investigative Site
Active, not recruiting
Catania, 95123
CT
Italy
Novartis Investigative Site
Active, not recruiting
Milano, 20132
MI
Italy
Novartis Investigative Site
Terminated
Cefalu, 90015
PA
Italy
Novartis Investigative Site
Terminated
Roma, 00133
RM
Italy
Novartis Investigative Site
Active, not recruiting
Roma, 00189
RM
Italy
Novartis Investigative Site
Recruiting
Gallarate, 21013
VA
Italy
Novartis Investigative Site
Terminated
Napoli, 80131
-
Italy
Latvia
Novartis Investigative Site
Completed
Riga, LV-1004
-
Latvia
Lithuania
Novartis Investigative Site
Active, not recruiting
Kaunas, LT 50161
LTU
Lithuania
Mexico
Novartis Investigative Site
Active, not recruiting
Ciudad De Mexico, 06700
D F
Mexico
Novartis Investigative Site
Active, not recruiting
Mexico, 03310
Distrito Federal
Mexico
Novartis Investigative Site
Withdrawn
Mexico, 06720
Distrito Federal
Mexico
Novartis Investigative Site
Withdrawn
México, 04530
Distrito Federal
Mexico
Novartis Investigative Site
Withdrawn
Merida, 97125
Yucatán
Mexico
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3015 CN
-
Netherlands
Poland
Novartis Investigative Site
Active, not recruiting
Lodz, 93-338
-
Poland
Novartis Investigative Site
Completed
Lublin, 20-093
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-355
-
Poland
Novartis Investigative Site
Recruiting
Wroclaw, 50 420
-
Poland
Puerto Rico
Novartis Investigative Site
Completed
Santurce, 00912
-
Puerto Rico
Romania
Novartis Investigative Site
Recruiting
Bucuresti, 041914
-
Romania
Russian Federation
Novartis Investigative Site
Active, not recruiting
Kazan, 420021
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Moscow, 119602
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Moscow, 119991
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
Novosibirsk, 630087
-
Russian Federation
Novartis Investigative Site
Active, not recruiting
St. Petersburg, 197110
-
Russian Federation
Serbia
Novartis Investigative Site
Active, not recruiting
Belgrade, 11000
-
Serbia
Novartis Investigative Site
Withdrawn
Kragujevac, 34000
-
Serbia
Novartis Investigative Site
Active, not recruiting
Novi Sad, 21000
-
Serbia
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 83340
Slovensko
Slovakia
Spain
Novartis Investigative Site
Active, not recruiting
Malaga, 29010
Andalucia
Spain
Novartis Investigative Site
Active, not recruiting
Sevilla, 41009
Andalucia
Spain
Novartis Investigative Site
Terminated
Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
Completed
Valencia, 46010
Comunidad Valenciana
Spain
Novartis Investigative Site
Active, not recruiting
Barakaldo, 48903
Pais Vasco
Spain
Novartis Investigative Site
Active, not recruiting
Madrid, 28006
-
Spain
Sweden
Novartis Investigative Site
Terminated
Lund, 221 85
-
Sweden
Turkey
Novartis Investigative Site
Terminated
Konak/Izmir, 35210
Izmir
Turkey
Novartis Investigative Site
Active, not recruiting
Istanbul, 34098
TUR
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06100
-
Turkey
Novartis Investigative Site
Completed
Ankara, 06500
-
Turkey
Novartis Investigative Site
Active, not recruiting
Izmir, 35340
-
Turkey
Novartis Investigative Site
Active, not recruiting
Samsun, 55139
-
Turkey
Ukraine
Novartis Investigative Site
Active, not recruiting
Cherkasy, 18000
-
Ukraine
Novartis Investigative Site
Active, not recruiting
Dnipropetrovsk, 49027
-
Ukraine
Novartis Investigative Site
Active, not recruiting
Kharkiv, 61068
-
Ukraine
Novartis Investigative Site
Terminated
Kharkiv, 61091
-
Ukraine
Novartis Investigative Site
Active, not recruiting
Kiev, 03110
-
Ukraine
Novartis Investigative Site
Active, not recruiting
Lviv, 79010
-
Ukraine
Novartis Investigative Site
Active, not recruiting
Odesa, 65009
-
Ukraine
Novartis Investigative Site
Active, not recruiting
Vinnytsa, 21029
-
Ukraine
United Kingdom
Novartis Investigative Site
Completed
West Midlands, B4 6NH
Birmingham
United Kingdom
Novartis Investigative Site
Active, not recruiting
Edinburgh, EH9 1LF
-
United Kingdom
Novartis Investigative Site
Active, not recruiting
London, WC1N 1EH
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]