A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Trial Profile

A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Dravet syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms GWPCARE1
  • Sponsors GW Pharmaceuticals
  • Most Recent Events

    • 04 Dec 2017 According to a company media release, company is anticipating that the FDA will accept the NDA of Epidiolex to treat Lennox-Gastaut syndrome (LGS) and Dravet syndrome in Dec 2017 and after acceptance, the PDUFA date expected mid 2018.
    • 30 Oct 2017 According to a company media release, GW pharmaceuticals and its US subsidiary Greenwich Biosciences have completed the rolling submission of an NDA to the US FDA for Epidiolex (cannabidiol) as an adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The NDA for Epidiolex is supported by data from three Phase 3 safety and efficacy studies.
    • 25 May 2017 Results published in a GW Pharmaceuticals media release.
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