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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2019

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At a glance

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

    • 23 Sep 2019 According to an GW Pharmaceuticals media release, the European Commission (EC) has approved the marketing authorisation for EPIDYOLEX for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.
    • 02 May 2019 According to a GW Pharmaceuticals media release, data will be presented at the 2019 American Academy of Neurology Annual Meeting.
    • 19 Apr 2018 According to an Epilepsy Foundation media release, Epilepsy Foundation too has supported the US FDA Peripheral and Central Nervous System Drug Advisory Committe's approval of Epidiolex for the treatment of Dravet and Lennox-Gastaut syndromes.
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