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

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Lennox-Gastaut syndrome; Seizures
  • Focus Registrational; Therapeutic Use
  • Acronyms GWPCARE4
  • Sponsors GW Pharmaceuticals
  • Most Recent Events

    • 04 Dec 2017 According to a company media release, company is anticipating that the FDA will accept the NDA of Epidiolex to treat Lennox-Gastaut syndrome (LGS) and Dravet syndrome in Dec 2017 and after acceptance, the PDUFA date expected mid 2018.
    • 30 Oct 2017 According to a company media release, GW pharmaceuticals and its US subsidiary Greenwich Biosciences have completed the rolling submission of an NDA to the US FDA for Epidiolex (cannabidiol) as an adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The NDA for Epidiolex is supported by data from three Phase 3 safety and efficacy studies.
    • 28 Apr 2017 Results presented at the 69th Annual Meeting of the American Academy of Neurology
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top