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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2019

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At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Lennox-Gastaut syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms GWPCARE4
  • Sponsors 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.
    • 25 Jun 2018 According to LGS foundation media release, the U.S. Food and Drug Administration (FDA) has approved EPIDIOLEX (cannabidiol / CBD) for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients two years age or older.
    • 27 Apr 2018 Results of a pooled analysis from GWPCARE 3 and GWPCARE 4 trials, presented at the 70th Annual Meeting of the American Academy of Neurology.
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