Interferon beta-1a: Administration once weekly via i.m. injections.
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.
Placebo capsule: Matching placebo capsule required for double-dummy masking to blind formulations.
Placebo i.m. injection: Matching placebo i.m. injection required for double-dummy masking to blind formulations.
Study summary
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)
Eligibility
Sex
ALL
Min age
10 Years
Max age
17 Years
Healthy volunteers
No
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.
1. 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
2. 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.
Primary outcome measure(s)
Frequency of Relapses in Patients Treated for up to 24 Months — 24 months Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
Trial sites (73)
Facility
City
Region
Status
UAB Childrens Hospital Harbor Center Neurology Dept
Birmingham
Alabama
Childrens Hospital Los Angeles
Los Angeles
California
UCSF
San Francisco
California
University of Miami
Miami
Florida
AMO Corporation
Tallahassee
Florida
Massachusetts General Hospital
Boston
Massachusetts
Wayne State University
Detroit
Michigan
Robert Wood Johnson Medical School
New Brunswick
New Jersey
Childrens Hospital of Philadelphia
Philadelphia
Pennsylvania
University of Utah Clinical Trials Office
Salt Lake City
Utah
Novartis Investigative Site
Parkville
Victoria
Novartis Investigative Site
Vienna
Austria
Novartis Investigative Site
Belo Horizonte
Minas Gerais
Novartis Investigative Site
Rio de Janeiro
Rio de Janeiro
Novartis Investigative Site
São Paulo
São Paulo
Novartis Investigative Site
Goiânia
Brazil
Novartis Investigative Site
Sofia
Bulgaria
Novartis Investigative Site
Calgary
Alberta
Novartis Investigative Site
Ottawa
Ontario
Novartis Investigative Site
Osijek
Croatia
Novartis Investigative Site
Tallinn
Estonia
Novartis Investigative Site
Bordeaux
France
Novartis Investigative Site
Le Kremlin-Bicêtre
France
Novartis Investigative Site
Marseille
France
Novartis Investigative Site
Montpellier
France
Novartis Investigative Site
Toulouse
France
Novartis Investigative Site
Freiburg im Breisgau
Baden-Wurttemberg
Novartis Investigative Site
Göttingen
Lower Saxony
Novartis Investigative Site
Dresden
Saxony
Novartis Investigative Site
Bochum
Germany
Novartis Investigative Site
Erlangen
Germany
Novartis Investigative Site
Bari
BA
Novartis Investigative Site
Montichiari
BS
Novartis Investigative Site
Catania
CT
Novartis Investigative Site
Milan
MI
Novartis Investigative Site
Cefalù
PA
Novartis Investigative Site
Roma
RM
Novartis Investigative Site
Roma
RM
Novartis Investigative Site
Gallarate
VA
Novartis Investigative Site
Riga
Latvia
+ 33 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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