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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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2019

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At a glance

  • Drugs Fingolimod (Primary) ; Interferon beta-1a
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms PARADIGMS
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 26 May 2019 This trial was completed in Hungary, according to European Clinical Trials Database.
    • 29 Nov 2018 According to a Novartis media release, based on the data from this study the European Commission (EC) has approved Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS). The EC decision is applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein.
    • 12 Oct 2018 Results evaluating the effect of fingolimod on quality of life in paediatric MS population, presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
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