A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults

Trial Profile

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Apr 2018

At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Lennox-Gastaut syndrome; Seizures
  • Focus Registrational; Therapeutic Use
  • Acronyms GWPCARE4
  • Sponsors GW Pharmaceuticals
  • Most Recent Events

    • 19 Apr 2018 According to a GW Pharmaceutical media release, the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously recommended supporting the approval of the New Drug Application (NDA) for Epidiolex, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients two years of age and older.
    • 05 Feb 2018 According to a GW Pharmaceuticals media release, based on this results, the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for Epidiolex (cannabidiol) for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
    • 26 Jan 2018 Results published in The Lancet.
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