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
Status: Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 23 Sep 2019
Price : $35 *
At a glance
- Drugs Cannabidiol (Primary)
- Indications Dravet syndrome; Lennox-Gastaut syndrome
- Focus Adverse reactions; Registrational
- Acronyms GWPCARE 5
- Sponsors GW Research
- 23 Sep 2019 According to an GW Pharmaceuticals media release, the European Commission (EC) has approved the marketing authorisation for EPIDYOLEX for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.
- 06 Jun 2019 Planned End Date changed from 1 Jun 2019 to 1 Jun 2020.
- 06 Jun 2019 Planned primary completion date changed from 1 Jun 2019 to 1 Jun 2020.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History