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

Phase 2

Completed

• Conditions: Focal Seizures; Epilepsy
• Interventions: Drug: GWP42006; Drug: Placebo Control

• Registration Number: NCT02365610
• Lead Sponsor: Jazz Pharmaceuticals

Brief 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.

Study Timeline

• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-19
• Study Start: 2016-03
• Primary Completion: 2017-07
• Study Completion: 2017-09
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GWP42006	GWP42006	GWP42006
Placebo control	Placebo Control	Placebo

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline to the end of treatment in focal seizure frequency in subjects taking GWP42006 compared to placebo.	Day -28 to Day 57

Secondary Outcome Measures

Name	Time	Method
Physician Global Impression of Change (PGIC) at the end of treatment.	Day 57
Number of subjects considered treatment responders.	Day -28 to Day 57
Change from baseline in seizure subtypes frequency.	Day -28 to Day 57
Change from baseline in composite seizure score.	Day -28 to Day 57
Change from baseline in the number of focal seizure free days.	Day -28 to Day 57
Change from baseline in the usage of rescue medication.	Day -28 to Day 57
Subject Global Impression of Change (SGIC).	Day 57
The incidence of adverse events as a measure of subject safety.	Day -28 to Day 96