Drug-drug interactions between Clobazam and GWP42003-P
Research type
Research Study
Full title
A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO INVESTIGATE POSSIBLE DRUG-DRUG INTERACTIONS BETWEEN CLOBAZAM AND CANNABIDIOL (GWP42003-P)
IRAS ID
183313
Contact name
Angus Clayton
Contact email
Eudract number
2014-002942-33
Duration of Study in the UK
1 years, 7 months, 23 days
Research summary
This is a double-blind, randomized, placebo-controlled study to investigate possible drug-drug interactions between Clobazam and the study medication, Cannabidiol (GWP42003-P) in adult epilepsy patients. The study will also assess the safety and tolerability of the study medication in the presence of Clobazam in controlling seizures.
Subjects will be randomised in a 4:1 ratio to receive GWP42003-P or placebo during the double blind section of the study. The treatment part of this will last approximately 5 weeks. All subjects will then be invited to participate in an open label extension whereby study medication will continue to be taken until market authorisation is granted or for a maximum of one year; whichever is earlier. A follow up phone call will take place four weeks after the last dose of GWP42003-P
Pharmacokinetic profiles will be collected at 2 timepoints during the double blind section of the study to investigate the quantities of the study medication, Clobazam and their major metabolites present in the blood over a 24 hour period.
Subjects will be required to complete a daily diary with information about their seizures (number and type of seizures); adverse events; concomitant antiepileptic drugs; usage of rescue medication; study medication dosing volumes.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0322
Date of REC Opinion
27 Oct 2015
REC opinion
Further Information Favourable Opinion