GWEP1415- Study of GWP42003-P in Dravet and Lennox-Gastaut Syndrome
Research type
Research Study
Full 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
IRAS ID
164303
Contact name
Adam Daniels
Contact email
Eudract number
2014-001834-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is an open-label, extension study that will provide free access to GWP42003-P for patients with Dravet or Lennox-Gastaut syndrome who have previously participated in double-blind, placebo-controlled studies of GWP42003-P conducted by GW Research Ltd (core studies). All patients will receive the dose of GWP42003-P recommended by the Data Safety Monitoring Committee (DSMC) in Part A of previous study GWEP1332.
Patients who completed all scheduled visits in their core study and consent to take part in the current study will be enrolled and will titrate up to the dose recommended from study GWEP1332. Patients will continue to receive this dose until study completion which is when GWP42003-P receives marketing authorisation, or a compassionate use programme becomes available in the country of a particular patient, or for a maximum of three years.
When the patient completes the study, there will be a 10-day taper period for patients who do not immediately continue to use GWP42003-P. All patients will complete a follow-up visit.
Assessments for all patients will include physical examinations, vital signs, 12-lead electrocardiogram, blood/urine samples, monitoring of adverse events and also monitoring of drug abuse liability (for patients 12 years or older). Additionally, patients or their caregiver will be asked to complete questionnaires on the patient’s quality of life and behaviour.
REC name
London - South East Research Ethics Committee
REC reference
14/LO/1794
Date of REC Opinion
14 Jan 2015
REC opinion
Further Information Favourable Opinion