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An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Adults With Dravet or Lennox-Gastaut Syndromes — GWPCARE5  

Epilepsy Clinical Trial

Official title:
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.

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02224573
Study type Interventional
Source Jazz Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date June 11, 2015
Completion date September 24, 2020
View Details
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