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A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study With Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)

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Trial Profile

A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study With Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Mar 2024

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At a glance

  • Drugs Vamorolone (Primary) ; Prednisone
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms VISION DMD
  • Sponsors ReveraGen BioPharma
  • Most Recent Events

    • 27 Mar 2024 According to a Santhera Pharmaceuticals media release, the Center for Drug Evaluation (CDE) of NMPA accepted the filing and granted priority review for vamorolone in DMD for patients aged 4 years and older which could, subject to a positive outcome, lead to approval by Q1 2025. Filing is supported by VISION-DMD in addition, the filing included data from three open-label studies and pharmacokinetic study in Chinese healthy volunteers.
    • 21 Feb 2024 Results published in the Santhera Pharmaceuticals Media Release.
    • 14 Feb 2024 According to a Santhera Pharmaceuticals media release, data from this study were published in the Neurology.
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