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

Epilepsy Clinical Trial

Official 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.

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Epilepsy
• Focal Seizures
• Seizures

• NCT number: NCT02365610
• Study type: Interventional
• Source: Jazz Pharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Completion date: September 2017