Last updated on February 2018

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

Brief description of study

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

Detailed Study Description

This study is a 1:1:1 randomized, double-blind, 14-week comparison of two Dose Levels of GWP42003-P versus placebo. A 28-day screening period prior to randomization (to establish baseline parameters) will precede the treatment period, which will consist of a two-week titration period followed by a 12-week maintenance period. The study will aim to determine the efficacy, safety and tolerability of GWP42003-P compared with placebo. The High Dose Level will be as recommended by the Data Safety Monitoring Committee (DSMC) after assessment of safety and pharmacokinetic data from Part A of study GWEP1332. The Low Dose Level will be defined as 50% of the High Dose Level. The first subject will not enroll into this study until the DSMC has reviewed the safety data from Part A of study GWEP1332.

Following study completion, all subjects will be invited to continue to receive GWP42003-P in an open label extension (OLE) study (under a separate protocol).

Clinical Study Identifier: NCT02224703

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Recruitment Status: Open

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