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A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures

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Trial Profile

A Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P, CBD) as Add-on Therapy in Patients With Tuberous Sclerosis Complex Who Experience Inadequately-controlled Seizures

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2024

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At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Generalised seizures; Seizures; Tuberous sclerosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms GWPCARE6
  • Sponsors GW Pharmaceuticals; GW Research

Most Recent Events

  • 10 Apr 2024 According to a Jazz Pharmaceuticals Inc media release, data from open label extension study will be featured at the 76th Annual American Academy of Neurology Meeting (AAN)
  • 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.
  • 27 Apr 2023 3 years results from GWPCARE6 Open-Label Extension presented at the 75th Annual Meeting of the American Academy of Neurology 2023

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