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A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis

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Trial Profile

A double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with primary progressive multiple sclerosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jan 2024

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At a glance

  • Drugs Fingolimod (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms INFORMS
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 01 Jan 2024 Results of retrospective analysis evaluating the incidence of newly appearing lesions developing into SELs, and their correlation to clinical evolution and treatment, published in the European Journal of Neurology
    • 04 Apr 2022 Results of post-hoc analysis NfL levels in two placebo-controlled, phase 3 studies in secondary progressive MS (SPMS; EXPAND) and primary progressive MS (PPMS; INFORMS), published in the 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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