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A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)

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Trial Profile

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Dec 2024

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At a glance

  • Drugs Viltolarsen (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms RACER-53
  • Sponsors NS Pharma

    • Most Recent Events

    • 27 May 2024 According to a NS Pharma Media Release, company is currently conducting further detailed data analyses, including post-hoc data analyses, and plans to work closely with regulatory authorities to determine how to proceed based on the results of this analysis and in the best interests of patients. The company will report on additional analyses and discussions with the regulatory authorities at a later date.
    • 27 May 2024 Preliminary results presented in a NS Pharma Media Release.
    • 28 Oct 2023 This trial has been completed in Norway (Date of the global end of the trial: 19-Oct-2023), according to the European Clinical Trials Database record.

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