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.
Phase of Trial: Phase III
Latest Information Update: 27 Feb 2018
At a glance
- Drugs Cannabidiol (Primary)
- Indications Seizures; Tuberous sclerosis
- Focus Adverse reactions; Registrational
- Sponsors GW Pharmaceuticals
- 27 Feb 2018 Based on the results of this trial, the Company expects to submit regulatory applications in 2019 for Epidiolex in Tuberous Sclerosis in both the U.S. and Europe, according to a GW Pharmaceuticals media release.
- 05 Feb 2018 According to a GW Pharmaceuticals media release, data from this trial is expected in H2 2018.
- 20 Oct 2017 Planned number of patients changed from 192 to 210.