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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)

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: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 05 Dec 2019

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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

    • 02 Oct 2019 Planned End Date changed from 1 Aug 2021 to 1 Dec 2022.
    • 02 Oct 2019 Planned primary completion date changed from 1 Aug 2021 to 1 Dec 2021.
    • 16 Sep 2019 According to a Wave life sciences media release, this study is also the first ever selected by the FDA for its Complex Innovative Trial Design (CID) pilot program.
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