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A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Study to Investigate 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: 27 Nov 2023

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At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Dravet syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms GWPCARE2
  • Sponsors GW Pharmaceuticals; GW Research; Jazz Pharmaceuticals Inc

Most Recent Events

  • 23 Nov 2023 According to a Jazz Pharmaceuticals Inc media release, Epidiolex (cannabidiol oral solution), has been approved by Health Canada for use as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 2 years of age and older, based on data from five double-blind, randomized, placebo-controlled Phase 3 clinical trials, with a total of 939 enrolled.
  • 01 Sep 2021 Results from NCT02224560, NCT02224690 NCT02091375, NCT02224703; evaluating safety of Cannabidiol in patients on Ketogenic Diet Therapy, presented at the 34th International Epilepsy Congress
  • 01 Sep 2021 Results of a pooled analysis (GWPCARE 1, 2, 3, and 4 studies) assessing the incidence and resolution of diarrhoea in patients taking CBD at 10 mg/kg/day (CBD10) or 20 mg/kg/day (CBD20), or matched placebo solution presented at the 34th International Epilepsy Congress

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