NCT02224573

An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes

An Open Label Extension Study to Investigate the Safety of Cannabidiol (GWP42003-P; CBD) in Children and Adults With Inadequately Controlled Dravet or Lennox-Gastaut Syndromes.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 681 (actual)
• Sponsor: GW Research Ltd · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and adults with Dravet or Lennox-Gastaut syndromes.

Detailed description

This is a multi-center, open-label extension study for participants with Dravet syndrome or Lennox-Gastaut syndrome who have previously participated in double-blind, placebo-controlled clinical studies of GWP42003-P (Core Studies: GWEP1332A \[NCT02091206\], GWEP1332B \[NCT02091375\], GWEP1424 \[NCT02224703\], GWEP1414 \[NCT02224560\], GWEP1424 \[NCT02224703\], and GWEP1423 \[NCT02224690\]). The first participant was enrolled into the open-label extension study after the Data Safety Monitoring Committee reviewed the safety data from Part A of study GWEP1332.

Conditions

• Epilepsy
• Dravet Syndrome
• Lennox-Gastaut Syndrome

Interventions

Type	Name	Description
DRUG	GWP42003-P

Timeline

• Start date: 2015-06-11
• Primary completion: 2020-09-24
• Completion: 2020-09-24
• First posted: 2014-08-25
• Last updated: 2022-02-03
• Results posted: 2022-02-03