A Phase III, Randomized, Double Blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

Trial Profile

A Phase III, Randomized, Double Blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Drisapersen (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms DEMAND III
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 24 Nov 2015 According to a BioMarin Pharmaceutical media release, The Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. FDA has reviewed the NDA for drisapersen for the treatment of duchenne muscular dystrophy amenable to exon 51 skipping.
    • 20 Nov 2015 According to a BioMarin Pharmaceutical media release, the Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the Kyndrisa NDA is December 27, 2015.
    • 20 Nov 2015 Results of pooled analysis of patients with comparable key baseline characteristics from this and two other clinical trials (700242338 and 700242354) published in a BioMarin Pharmaceutical media release.
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