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24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

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24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Nov 2023

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At a glance

  • Drugs Fingolimod (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms FREEDOMS-II
  • Sponsors Novartis

    • Most Recent Events

    • 13 Oct 2023 Results of pooled analysis (from studies ASCLEPIOS I/II for OFAand from FREEDOMS I, II and TRANSFORMS for FIN) assessing Indirect Treatment Comparison Methodologies to Differentiate the Efficacy of Ofatumumab and Other High Efficacy Therapies versus Orally Administered Disease Modifying Therapies for Relapsing Multiple Sclerosispresented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research
    • 16 Jan 2023 Results of post-hoc analysis assessing the potential of retinal nerve fiber layer thickness (RNFLT) measured with optical coherence tomography in predicting disease progression in relapsing-remitting multiple sclerosis, published in the European Journal of Neurology.
    • 01 Nov 2021 Results of PSM-based ITC analysis from following clinical trials: EXPAND, INFORMS, FREEDOMS, FREEDOMS-II, TRANSFORMS, ASCLPEIOS-I and ASCLPEIOS-II published in the Current Medical Research and Opinion

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