GWEP1330 - A Study of GWP42006 in people with focal seizures
Research type
Research Study
Full title
A double blind, randomized, placebo-controlled, two-part study to investigate the pharmacokinetics, followed by efficacy and safety of GWP42006 as add-on therapy in patients with inadequately controlled focal seizures
IRAS ID
165015
Contact name
Adam Daniels
Contact email
Eudract number
2014-002594-11
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
This is a double blind, randomized, placebo-controlled, two-part study to investigate the pharmacokinetics, followed by efficacy and safety of GWP42006 as add-on therapy in patients with inadequately controlled focal seizures.
Part A:
Part A consists of a two-week baseline period and a two-week treatment period. Patients will be required to attend six study visits. A follow-up phone call will take place four weeks after last dose.
Part A will enrol three groups of 10 patients:
• Group 1 - patients on inducer AEDs (and not on inhibitor AEDs).
• Group 2 - patients on inhibitor AEDs (and not on inducer AEDs).
• Group 3 - patients on AEDs that are neither inducers nor inhibitors.
In each of the three groups, patients will be randomized to receive, in a 4:1 ratio, GWP42006 or matching placebo.
PK profiles for GWP42006 and metabolites will be collected on the first and last day of treatment.
Patients will be required to record a daily diary with information about their seizures, IMP and concomitant AED administration.
When all patients have completed treatment, the PK and safety data will be reviewed by the Data Safety Monitoring Committee (DSMC) which will advise on dosing and eligibility criteria adjustments Part B.Part B:
Part B consists of a four-week baseline period, a two-week dose escalation period, a six-week stable treatment period and a 12-day taper period. Patients will be required to attend eight study visits. A follow-up phone call will take place four weeks after last dose.
Patients will be randomized to receive in a 1:1 ratio, GWP42006 or placebo.
Patients will be required to record a daily diary with information about their seizures, IMP and concomitant AED administration.Eligible participants will not be required to stop any of their current treatments or medications.
REC name
London - City & East Research Ethics Committee
REC reference
14/LO/2101
Date of REC Opinion
24 Jan 2015
REC opinion
Further Information Favourable Opinion