GWEP1424 - Study of GWP42003-P in Dravet Syndrome
Research type
Research Study
Full title
A randomized double-blind, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
IRAS ID
164579
Contact name
Adam Daniels
Contact email
Sponsor organisation
GW Pharmaceuticals Ltd
Eudract number
2014-002939-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 17 days
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 III, double-blind, two-part, multicentre study.Participants in the study will receive either GWP42003-P or placebo. However, they will not know which treatment they have been assigned.
Participants will be aged between 2 and 18 years old and will be randomly assigned one of two doses of GWP42003-P or placebo. The ratio of GWP42003-P high dose to GWP42003-P low dose to placebo will be 1:1:1 with participants having a 66% chance of receiving GWP42003-P and a 33% chance of receiving placebo. The doses will be based on the safety information collected in the study GWP1332. The high dose will be the dose recommended from this study and the low dose will be 50% of the recommended dose.
The study will last up to 20 weeks, including a dosing period lasting 14 weeks. Participants will attend six or seven study visits and up to three additional visits over the phone. Assessments will include vital signs, physical examination, blood/urine samples, electrocardiogram and monitoring of adverse events. The participant’s caregiver will also complete questionnaires on sleep, quality of life and behaviour. The participant will complete a battery of cognitive assessments and be asked about their mental health. A diary will be completed by the participant or caregiver throughout the study.
All participants who complete the study will be invited to enter an open-label extension study.
REC name
London - South East Research Ethics Committee
REC reference
14/LO/2114
Date of REC Opinion
29 Dec 2014
REC opinion
Unfavourable Opinion