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: 05 Dec 2017

At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Dravet syndrome; Lennox-Gastaut syndrome; Seizures
  • Focus Adverse reactions; Registrational
  • Acronyms GWPCARE 5
  • Sponsors GW Pharmaceuticals
  • Most Recent Events

    • 05 Dec 2017 Results of the first pre-specified interim analysis (n=366; data cut-off: 3 Nov 2016) in patients with Lennox-Gastaut Syndrome (LGS), presented at the 71st Annual Meeting of the American Epilepsy Society.presented at the 71st Annual Meeting of the American Epilepsy Society.
    • 05 Dec 2017 This trial includes two interim analyses to support regulatory submissions, according to the results of the first pre-specified interim analysis in patients with Dravet Syndrome, presented at the 71st Annual Meeting of the American Epilepsy Society.
    • 05 Dec 2017 Results of the first pre-specified interim analysis (n=264; data cut-off: 3 Nov 2016) in patients with Dravet Syndrome (DS), presented at the 71st Annual Meeting of the American Epilepsy Society.
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