An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes

Trial Profile

An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes

Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2017

At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Dravet syndrome; Lennox-Gastaut syndrome
  • Focus Adverse reactions; Registrational
  • Sponsors GW Pharmaceuticals
  • Most Recent Events

    • 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.
    • 27 Jan 2016 Planned End Date changed from 1 Jan 2018 to 1 Jun 2016, according to ClinicalTrials.gov record.
    • 27 Jan 2016 Planned primary completion date changed from 1 Jan 2018 to 1 Jun 2016, according to ClinicalTrials.gov record.
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