Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis
NCT ID: NCT01892722
Last Updated: 2025-11-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2013-07-26
2030-02-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fingolimod
Fingolimod was administered orally once daily at a dose of either 0.5 mg or 0.25 mg (depending on patient's body weight) with the aim to achieve systemic exposure in range of that in adults at the licensed 0.5 mg dose. Participants in this arm during core continued into extension and received open-label treatment
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.
Interferon beta-1a
An intramuscular (IM) injection of Interferon beta-1a was administered once weekly during core phase. Participants switched to receive open-label fingolimod in extension phase
Interferon beta-1a
Administration once weekly via i.m. injections.
Placebo i.m. injection
Matching placebo i.m. injection required for double-dummy masking to blind formulations.
Fingolimod-Younger Cohort
The 'younger cohort' refers to the new pediatric patients to be recruited in the extension phase who fulfill any single one or a combination of the following criteria: being ≤12 years of age, or weighing ≤40 kg, or being prepubertal (i.e. pubertal status of Tanner stage \<2)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Applies to patients newly recruited to participate in the Extension Phase.
* Central review (including initial MRI report) of the diagnosis of pediatric MS will be required for all newly recruited patients.
Exclusion Criteria
* 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
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
Applies to patients newly recruited in the younger cohort to participate in the Extension Phase.
10 Years
17 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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UAB Childrens Hospital Harbor Center Neurology Dept
Birmingham, Alabama, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
UCSF
San Francisco, California, United States
University of Miami
Miami, Florida, United States
AMO Corporation
Tallahassee, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Utah Clinical Trials Office
Salt Lake City, Utah, United States
Novartis Investigative Site
Parkville, Victoria, Australia
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Vienna, , Austria
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Belo Horizonte, Minas Gerais, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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São Paulo, São Paulo, Brazil
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Goiânia, , Brazil
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Sofia, , Bulgaria
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Calgary, Alberta, Canada
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Ottawa, Ontario, Canada
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Osijek, , Croatia
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Tallinn, , Estonia
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Bordeaux, , France
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Le Kremlin-Bicêtre, , France
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Marseille, , France
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Montpellier, , France
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Toulouse, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Göttingen, Lower Saxony, Germany
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Dresden, Saxony, Germany
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Bochum, , Germany
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Erlangen, , Germany
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Bari, BA, Italy
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Montichiari, BS, Italy
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Catania, CT, Italy
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Milan, MI, Italy
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Cefalù, PA, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Gallarate, VA, Italy
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Riga, , Latvia
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Kaunas, LTU, Lithuania
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Mexico City, D F, Mexico
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Distrito Federal, , Mexico
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Rotterdam, South Holland, Netherlands
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Wroclaw, , Poland
San Jorge Childrens Hospital
Santurce, , Puerto Rico
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Bucharest, , Romania
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Kazan', , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Belgrade, , Serbia
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Bratislava, , Slovakia
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Seville, Andalusia, Spain
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Vigo, Pontevedra, Spain
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Barakaldo, Vizcaya, Spain
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Madrid, , Spain
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Málaga, , Spain
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Valencia, , Spain
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Samsun, Atakum, Turkey (Türkiye)
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Izmir, Balcova, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Ankara, Sihhiye-Altindag, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Kharkiv, , Ukraine
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West Midlands, Birmingham, United Kingdom
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Edinburgh, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Countries
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References
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Deiva K, Huppke P, Banwell B, Chitnis T, Gartner J, Krupp L, Waubant E, Stites T, Pearce GL, Merschhemke M. Consistent control of disease activity with fingolimod versus IFN beta-1a in paediatric-onset multiple sclerosis: further insights from PARADIGMS. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):58-66. doi: 10.1136/jnnp-2019-321124. Epub 2019 Aug 29.
Chitnis T, Arnold DL, Banwell B, Bruck W, Ghezzi A, Giovannoni G, Greenberg B, Krupp L, Rostasy K, Tardieu M, Waubant E, Wolinsky JS, Bar-Or A, Stites T, Chen Y, Putzki N, Merschhemke M, Gartner J; PARADIGMS Study Group. Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis. N Engl J Med. 2018 Sep 13;379(11):1017-1027. doi: 10.1056/NEJMoa1800149.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2011-005677-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CFTY720D2311
Identifier Type: -
Identifier Source: org_study_id
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