A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Trial Profile

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2017

At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Dravet syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors GW Pharmaceuticals
  • Most Recent Events

    • 21 Sep 2017 Planned number of patients changed from 150 to 186.
    • 26 Sep 2016 According to a GW Pharmaceuticals media release, the company plans to submit a NDA for cannabidiol (Epidiolex) to the US FDA in the first half of 2017.
    • 11 Aug 2016 Planned End Date changed from 1 Aug 2016 to 1 Jun 2017.
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