NCT02365610

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

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: 162 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To investigate the potential antiepileptic effects of GWP42006 as add-on therapy in subjects with inadequately controlled focal seizures.

Detailed description

This is a double blind, randomized, placebo controlled, two-part study. Part B only will be described in this record. Subjects who satisfy all inclusion and none of the exclusion criteria will enter a four-week baseline period, followed by a two-week dose escalation period (400 mg twice daily for one week, then 600 mg twice daily for one week), a six-week stable treatment period (800 mg twice daily) and a 12-day taper period. Subjects will be required to attend eight study visits. A follow-up phone call will take place four weeks after last dose. Subjects will be randomized to receive in a 1:1 ratio, GWP42006 or placebo. Subjects will be required to record a daily diary with information about their seizures, investigational medicinal product (IMP) and concomitant antiepileptic drug (AED) administration.

Conditions

• Epilepsy
• Focal Seizures

Interventions

Type	Name	Description
DRUG	GWP42006
DRUG	Placebo Control

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2015-02-19
• Last updated: 2022-12-20

Locations

26 sites across 6 countries: Czechia, Hungary, Italy, Poland, Spain, United Kingdom