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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

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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: 27 Nov 2023

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At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Generalised seizures; Lennox-Gastaut syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms GWPCARE3
  • Sponsors GW Pharmaceuticals; GW Research

    • 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.
    • 13 Apr 2023 Results (n=396) of a post-hoc analysis assessing seizure-free days as a potential new outcome measure from two phase 3 clinical trials (GWPCARE3, GWPCARE4) in patients with Lennox-Gastaut syndrome published in the Epilepsia
    • 06 Dec 2022 Pooled post hoc results from GWPCARE3 and GWPCARE4 studies (n=396 ) evaluating the change from baseline in the number of drop seizure-free days per 28 days, presented at the 76th Annual Meeting of the American Epilepsy Society.

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