NCT02369471

A Study of GWP42006 in People With Focal Seizures - Part A

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo, in the presence of other antiepileptic drugs (AEDs).

Detailed description

This is a double blind, randomized, placebo controlled, two-part study. Part A only will be described in this record. Subjects who satisfy all inclusion and none of the exclusion criteria will begin a 14-day baseline observation period followed by a 14-day treatment period. Subjects will be required to attend six study visits. A follow-up phone call will take place four weeks after last dose. Part A will enroll three groups of 10 subjects: * Group 1 - subjects on inducer AEDs (and not on inhibitor AEDs) * Group 2 - subjects on inhibitor AEDs (and not on inducer AEDs) * Group 3 - subjects on AEDs that are neither inducers nor inhibitors. In each of the three groups subjects will be randomized to receive, in a 4:1 ratio, GWP42006 400 mg twice daily or matching placebo. Pharmacokinetic (PK) profiles for GWP42006 and metabolites will be collected on the first and last day of treatment. Samples will also be collected 24h and 72h after the last day of treatment. Subjects will be required to record a daily diary with information about their seizures, investigational medicinal product (IMP) and concomitant AED administration.

Conditions

• Epilepsy
• Focal Seizures

Interventions

Type	Name	Description
DRUG	GWP42006
DRUG	Placebo

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-10-01
• Completion: 2015-11-01
• First posted: 2015-02-24
• Last updated: 2022-12-20

Locations

9 sites across 3 countries: Czechia, Spain, United Kingdom