Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097

NCT ID: NCT00310388

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-05
• Study Completion Date: 2018-05-24

Brief Summary

This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until the subject withdraws from the study or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The primary objective of the study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the double-blind Study VRX-RET-E22-302. Secondary objectives are: to evaluate efficacy of long-term treatment with retigabine and patient quality of life and to evaluate whether retinal pigmentation, unexplained vision loss, pigmentation of non-retinal ocular tissue, and discoloration of nails, lips, skin or mucosa change over time after discontinuation of retigabine.

Detailed Description

This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-302 trial. Patients who have completed the VRX-RET-E22-302 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 55-60 sites in Europe, Israel, Australia, and South Africa. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.

Conditions

Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Retigabine (INN), Ezogabine (USAN)

Retigabine (Ezogabine): all subjects

Group Type: EXPERIMENTAL

Retigabine (INN), Ezogabine (USAN)

Intervention Type: DRUG

Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.

Interventions

Retigabine (INN), Ezogabine (USAN)

Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patients receives between 600 and 1200 mg of retigabine per day. The duration will be until the completion of the trial, or until the patient withdraws from the trial.

Intervention Type: DRUG

Other Intervention Names

GW582892X; D-23129; GKE-841

Eligibility Criteria

Inclusion Criteria

• Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-302 for the treatment of partial-onset seizures
• Patient is expected to benefit from participation in the study in the opinion of the Investigator.

Exclusion Criteria

• Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-302 study or is experiencing an ongoing serious adverse event.
• Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.
• Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Institute of Clniical Neurosciences

Camperdown, New South Wales, Australia

North Coast Neurology Centre

Maroochydore, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Austin & Repatriation Medical Centre

West Heidelberg, Victoria, Australia

General Hospital Middelheim -- Department of Neurology

Antwerp, , Belgium

AZ Sint-Jan

Bruges, , Belgium

Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology

Leuven, , Belgium

Centre Neurologique William Lennox

Ottignies, , Belgium

Hopital Civil de Steasbourg Clinique Neurologie

Levallois-Perret, , France

Hopital Neurologique Pierre Wertheimer

Lyon, , France

CHU Pontchaillou

Rennes, , France

Centre Medical de La Teppe

Tain-l'Hermitage, , France

Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen

Erlangen, Bavaria, Germany

Universitaet Giessen / Marburg Neurologie

Marburg, Hesse, Germany

Universitaetsklinik Mainz Neurologische Klinik

Mainz, Rhineland-Palatinate, Germany

University of Bonn -- Department for Epileptplogy

Bonn, , Germany

Private Neurologische Paraxis

Muenchen, by, , Germany

Universitaetslinkum Ulm Poliklinik fuer Neurologie

Ulm, BW, , Germany

Pecs University of Science, Clinic of Neurology

Pécs, Ret, Hungary

Orszagos Pszichiatriai es Neurologiai Intezet

Budapest, , Hungary

Orszagos Idegsebeszeti Tudomanyos Intezet

Budapest, , Hungary

Assaf Harofeh Medical Center

Beer Yaakov, , Israel

Rambam Medical Center

Haifa, , Israel

Wolfson Medical Center

Holon, , Israel

Western Galilee Hospital

Nahariya, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel-Aviv Sourasky Medical Center

Tel Aviv, , Israel

Specjalistyczna Przychodnia Lekarska Medikard

Padlewskiego 4, Plock, Poland

Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"

Plac Hallera 5, Warszawa, Poland

Oddzial Neurologii -- Klinika Neurologii ICZMP

U1. Parzeczewska 35, Zgierz, Poland

NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"

Bialystok, , Poland

Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika

Gdansk, , Poland

WSS im.Kardynala S. Wyszynskiego

Lublin, , Poland

Instytut Psychiatrii i Neurologii II Oddzial Neurologii

Warsaw, , Poland

Kazan State Medical University

Kazan', , Russia

City Hospital # 1

Moscow, , Russia

City Hospital # 33

Moscow, , Russia

District Antiepileptic Centre City Clinical Hospital # 71

Moscow, , Russia

Russian Military Medical Academy

Saint Petersburg, , Russia

Pavlov State Medical University Clinic and Department of Neurology

Saint Petersburg, , Russia

Sunninghill & Kopano Clinical Trials

Johannesburg, Gauteng, South Africa

Wilgers MR & Medical Centre

Pretoria, Gauteng, South Africa

Panorama Medi-Clinic

Parow, W Cape, South Africa

Groote Schuur Hospital

Cape Town, WC, South Africa

Carl Bremer Hospital

Belville, W Cape, , South Africa

Farmovs Parexel

BleomFontein, Free State, , South Africa

Inkosi Albert Luthuli Central Hospital

Durban, KZ-Natal, , South Africa

Johannesburg Hospital

Johannesburg, Gauteng, , South Africa

Triple M Research

Port Elisabeth, E Cape, , South Africa

Hospital Sta. Creu i S. Pau

Barcelona, , Spain

Hospital de Cruces Neurology Department

Bilbao, , Spain

Hosp. de Donostia Neurology Department

Donostia / San Sebastian, , Spain

Hosp. Virgen de las Nieves

Granada, , Spain

Hospital Ruber Internacional de Madrid

Madrid, , Spain

Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario Lozano Blesa Neurology Service

Zaragoza, , Spain

Psychosomatic Center of Dnepropetr. Regional Clinic

Dnipro, , Ukraine

Kharkov State Medical University

Kharkiv, , Ukraine

Institute of Neurology, Psychiatry and Narcology of AMS, Ukr

Kharkiv, , Ukraine

Epilepsy Center of Municipal Clinical Psychoneurological Hospital

Kiev, , Ukraine

Odessa Regional Clinical Hospital Center for Neurology and Neurosurgery

Odesa, , Ukraine

The James Cook University Hospital

Middlesbrough, Mersyd, United Kingdom

Fylde Coast Hospital

Blackpool, , United Kingdom

Western Infirmary (Epilepsy)

Glasgow, , United Kingdom

Royal London Hospital

London, , United Kingdom

Countries

Australia; Belgium; France; Germany; Hungary; Israel; Poland; Russia; South Africa; Spain; Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

EUDRACT No. 2006-000956-42

Identifier Type: -

Identifier Source: secondary_id

RTG115097

Identifier Type: OTHER

Identifier Source: secondary_id

VRX-RET-E22-304

Identifier Type: -

Identifier Source: org_study_id