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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: 08 Dec 2023

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At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Seizures; Tuberous sclerosis
  • Focus Adverse reactions; Registrational
  • Acronyms GWPCARE6; GWPCARE6 OLE
  • Sponsors Jazz Pharmaceuticals Inc

    • Most Recent Events

    • 01 Dec 2023 According to a Jazz Pharmaceuticals Plc media release, post-hoc analysis of the GWPCARE6 Open-Label Extension (OLE) trial evaluating the effectiveness of Epidiolex will be presented at the 2023 American Epilepsy Society (AES) annual meeting, being held December 1-5 in Orlando, Florida.
    • 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.
    • 06 Dec 2022 Results(3-year Results) assessing safety and efficacy (safety for the full follow-up and efficacy through 156 wks) of Add-on Cannabidiol (CBD) for Seizures Associated with Tuberous Sclerosis Complex of treatment presented at the 76th Annual Meeting of the American Epilepsy Society

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