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An Open-Label, Multi-Center, Study With a Concurrent Untreated Control Arm to Evaluate the Efficacy and Safety of Eteplirsen in Duchenne Muscular Dystrophy

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Trial Profile

An Open-Label, Multi-Center, Study With a Concurrent Untreated Control Arm to Evaluate the Efficacy and Safety of Eteplirsen in Duchenne Muscular Dystrophy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2022

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At a glance

  • Drugs Eteplirsen (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms PROMOVI
  • Sponsors Sarepta Therapeutics

Most Recent Events

  • 01 Sep 2022 Results of post-hoc pooled analysis comparing percentage of predicted forced vital capacity and projected time with pulmonary function in patients with Duchenne muscular dystrophy from clinical studies 204 and 301 or standard of care (SoC; Cooperative International Neuromuscular Research Group Duchenne Natural History Study) published in the Muscle and Nerve
  • 14 Sep 2020 According to a Sarepta Therapeutics media release, data from this study will be presented at the WMS25 Virtual Congress, the 25th International Annual Congress of the World Muscle Society. The company will host a webcast and conference call on Sept. 28, 2020.
  • 01 May 2020 Results of an analysis from two clinical studies: study 204 (n=20) and study 301 (n=42) assessing temporal patterns of forced vital capacity in glucocorticoid-treated patients were presented at the 72nd Annual Meeting of the American Academy of Neurology

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