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A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51)

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51)

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Suvodirsen (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms DYSTANCE 51
  • Sponsors WaVe life Sciences

    • Most Recent Events

    • 07 Jan 2020 The trial is discontinued in Germany,according to European Clinical Trials Database record.
    • 17 Dec 2019 Planned End Date changed from 1 Dec 2022 to 31 Mar 2020.
    • 16 Dec 2019 According to a WaVe life Sciences media release, the company is discontinuing the development of suvodirsen for patients with Duchenne muscular dystrophy (DMD) who have mutations amenable to exon 51 skipping, based on the interim data from open-label extension study because there is no change from baseline in dystrophin expression, as measured by western blot, with either the 3.5 mg/kg or 5 mg/kg doses of suvodirsen. No safety concerns or emerging safety signals were observed.
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