An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Young Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes
Phase of Trial: Phase III
Latest Information Update: 17 Aug 2017
At a glance
- Drugs Cannabidiol (Primary)
- Indications Dravet syndrome; Lennox-Gastaut syndrome
- Focus Adverse reactions; Registrational
- Sponsors GW Pharmaceuticals
- 26 Sep 2016 According to a GW Pharmaceuticals media release, the company plans to submit a NDA for cannabidiol (Epidiolex) to the US FDA in the first half of 2017.
- 27 Jan 2016 Planned End Date changed from 1 Jan 2018 to 1 Jun 2016, according to ClinicalTrials.gov record.
- 27 Jan 2016 Planned primary completion date changed from 1 Jan 2018 to 1 Jun 2016, according to ClinicalTrials.gov record.