GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Summary

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

Timeline

Start

2015-04-13

Primary completion

2018-04-09

Completion

2018-04-09

Outcome

Met primary endpoint

registry analysis (superiority test); 10 mg/kg/Day GWP42003-P vs Placebo Control; p = 0.0095; Treatment Ratio 0.702 (95% CI 0.538 to 0.916) NCT02224703 ↗

registry analysis (superiority test); 20 mg/kg/Day GWP42003-P vs Placebo Control; p = 0.0299; Treatment Ratio 0.743 (95% CI 0.568 to 0.971) NCT02224703 ↗

Publications

• Madan Cohen J, Checketts D, Dunayevich E, Gunning B, Hyslop A, Madhavan D, Villanueva V, Zolnowska M, Zuberi SM. Time to onset of cannabidiol treatment effects in Dravet syndrome: Analysis from two randomized controlled trials. Epilepsia. 2021 Sep;62(9):2218-2227. doi: 10.1111/epi.16974. Epub 2021 Jul 15.
• Miller I, Scheffer IE, Gunning B, Sanchez-Carpintero R, Gil-Nagel A, Perry MS, Saneto RP, Checketts D, Dunayevich E, Knappertz V; GWPCARE2 Study Group. Dose-Ranging Effect of Adjunctive Oral Cannabidiol vs Placebo on Convulsive Seizure Frequency in Dravet Syndrome: A Randomized Clinical Trial. JAMA Neurol. 2020 May 1;77(5):613-621. doi: 10.1001/jamaneurol.2020.0073.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	10 mg/kg	Oral
Subject	Cannabidiol	Other / unclassified	20 mg/kg	Oral

Indications