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

Last Update: Mar 09, 2021

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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 
220 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
Recruiting
Los Angeles, 90027
California
United States
Novartis Investigative Site
Recruiting
Tallahassee, 32308
Florida
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
Recruiting
Goiania, 74605 020
-
Brazil
France
Novartis Investigative Site
Recruiting
Le Kremlin Bicetre, 94275
-
France
Italy
Novartis Investigative Site
Recruiting
Montichiari, 25018
BS
Italy
Novartis Investigative Site
Recruiting
Catania, 95123
CT
Italy
Novartis Investigative Site
Recruiting
Roma, 00189
RM
Italy
Novartis Investigative Site
Recruiting
Gallarate, 21013
VA
Italy
Mexico
Novartis Investigative Site
Recruiting
Mexico, 03310
Distrito Federal
Mexico
Netherlands
Novartis Investigative Site
Recruiting
Rotterdam, 3015 CN
-
Netherlands
Poland
Novartis Investigative Site
Recruiting
Wroclaw, 50 420
-
Poland
Puerto Rico
Novartis Investigative Site
Recruiting
Santurce, 00912
-
Puerto Rico
Romania
Novartis Investigative Site
Recruiting
Bucuresti, 041914
-
Romania
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 119602
-
Russian Federation
Novartis Investigative Site
Recruiting
Moscow, 119991
-
Russian Federation
Serbia
Novartis Investigative Site
Recruiting
Belgrade, 11000
-
Serbia
Novartis Investigative Site
Recruiting
Novi Sad, 21000
-
Serbia
Slovakia
Novartis Investigative Site
Recruiting
Bratislava, 83340
Slovensko
Slovakia
Spain
Novartis Investigative Site
Recruiting
Barakaldo, 48903
Pais Vasco
Spain
Turkey
Novartis Investigative Site
Recruiting
Ankara, 06100
-
Turkey
Ukraine
Novartis Investigative Site
Recruiting
Cherkasy, 18000
-
Ukraine
Novartis Investigative Site
Recruiting
Dnipropetrovsk, 49027
-
Ukraine
Novartis Investigative Site
Recruiting
Kharkiv, 61068
-
Ukraine
Novartis Investigative Site
Recruiting
Kiev, 03110
-
Ukraine
Novartis Investigative Site
Recruiting
Lviv, 79010
-
Ukraine
Novartis Investigative Site
Recruiting
Odesa, 65009
-
Ukraine
Novartis Investigative Site
Recruiting
Vinnytsa, 21029
-
Ukraine
United Kingdom
Novartis Investigative Site
Recruiting
London, WC1N 1EH
-
United Kingdom
Novartis Investigative Site
Recruiting
London, WC1N 3BG
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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