GWEP1332 - Study of GWP42003-P in Dravet Syndrome
Research type
Research Study
Full title
A double-blind, placebo-controlled, two-part study to investigate the dose-ranging safety and pharmacokinetics, followed by the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet Syndrome.
IRAS ID
157630
Contact name
Helen Cross
Contact email
Sponsor organisation
GW Pharmaceuticals Ltd
Eudract number
2014-000995-24
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT02091375, Study Part B ClinicalTrials.gov identifier (NCT)
Research summary
This clinical study is being conducted by GW Pharma Ltd to determine the safety and efficacy of the drug GWP42003-P in children and young adults with Dravet syndrome.
This is a Phase II/III, double-blind, two-part, multicentre study. Participants in both parts of the study will receive either GWP42003-P or placebo, however they will not know which treatment they have been assigned.
In the first part of the study, participants will be aged between 4 and 10 years old and will be randomly assigned to one of three doses of GWP42003-P or placebo. The ratio of GWP42003-P to placebo will be 4:1; study participants will have an 80 % chance of receiving GWP42003-P and a 20 % chance of receiving placebo. This part of the study will last for up to 13 weeks, with a treatment period of three weeks, followed by a 10 day taper period. In this part of the study there will be up to six study visits at the study clinic and one visit via telephone if applicable.
In the second part of the study, participants will be aged between 2 and 18 years old and will be randomly assigned to GWP42003-P or placebo. The ratio of GWP42003-P to placebo will be 1:1, with participants having a 50 % chance of receiving GWP42003-P and 50 % chance of receiving placebo. One dose of GWP42003-P will be administered, which will be based on safety information collected in the first part of the study. This part of the study will last for up to 24 weeks, with a treatment period of 14 weeks. In this part of the study, there will be up to seven study visits at the study clinic and up to three visits via telephone.
In both study parts, assessments will include vital signs, physical examination, blood/urine samples, electrocardiogram and monitoring of adverse events. In the second part of the study, questionnaires on the participant’s sleep, quality of life and behaviour will also be completed by the participant’s caregiver. A diary will be completed daily by participants or participant’s caregiver in both parts of the study.
All participants who complete either part of the study will be invited to enter an open-label extension study.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/1387
Date of REC Opinion
9 Sep 2014
REC opinion
Favourable Opinion