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
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 GWPCARE3
- Sponsors GW Pharmaceuticals
- 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.
- 18 Apr 2017 Positive results published in the GW Pharmaceuticals media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History