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: 29 Dec 2017

At a glance

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

    • 29 Dec 2017 According to a GW Pharmaceuticals media release, the company has submitted its Marketing Authorisation Application (MAA) to the EMA for Epidiolex as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The MAA is based on 3 phase III studies.
    • 28 Dec 2017 According to a GW Pharmaceuticals, the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for Epidiolex for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018.
    • 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.
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