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

Last updated: October 16, 2018
Sponsor: GlaxoSmithKline
Overall Status: Terminated

Phase

3

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT00310388
VRX-RET-E22-304
EUDRACT No. 2006-000956-42
RTG115097
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient has successfully completed the Maintenance and Transition phases of StudyVRX-RET-E22-302 for the treatment of partial-onset seizures

  • Patient is expected to benefit from participation in the study in the opinion of theInvestigator.

Exclusion

Exclusion Criteria:

  • Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-302 study oris experiencing an ongoing serious adverse event.

  • Patient is receiving any investigational drug or using any experimental device inaddition to Retigabine for treatment of epilepsy or any other medical condition.

  • Patient has any other condition that would prevent compliance with the studyprocedures or proper reporting of adverse events.

Study Design

Total Participants: 376
Study Start date:
July 05, 2006
Estimated Completion Date:
May 24, 2018

Study 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.

Connect with a study center

  • Institute of Clniical Neurosciences

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • North Coast Neurology Centre

    Maroochydore, Queensland 4558
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5041
    Australia

    Site Not Available

  • Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Austin & Repatriation Medical Centre

    West Heidelberg, Victoria 3081
    Australia

    Site Not Available

  • General Hospital Middelheim -- Department of Neurology

    Antwerp, B-2020
    Belgium

    Site Not Available

  • AZ Sint-Jan

    Brugge, 8000
    Belgium

    Site Not Available

  • Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology

    Leuven, 3000
    Belgium

    Site Not Available

  • Centre Neurologique William Lennox

    Ottignies, 1340
    Belgium

    Site Not Available

  • Hopital Civil de Steasbourg Clinique Neurologie

    Levallois-Perret, 92594
    France

    Site Not Available

  • Hopital Neurologique Pierre Wertheimer

    Lyon, 69003
    France

    Site Not Available

  • CHU Pontchaillou

    Rennes Cedex, 35033
    France

    Site Not Available

  • Centre Medical de La Teppe

    Tain L'Hermitage, 26, 26600
    France

    Site Not Available

  • Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen

    Erlangen, BY 91054
    Germany

    Site Not Available

  • Universitaet Giessen / Marburg Neurologie

    Marburg, HE 35033
    Germany

    Site Not Available

  • Universitaetsklinik Mainz Neurologische Klinik

    Mainz, RP 55101
    Germany

    Site Not Available

  • University of Bonn -- Department for Epileptplogy

    Bonn, D-53105
    Germany

    Site Not Available

  • Private Neurologische Paraxis

    Muenchen, BY, 80333
    Germany

    Site Not Available

  • Universitaetslinkum Ulm Poliklinik fuer Neurologie

    Ulm, BW, 89081
    Germany

    Site Not Available

  • Pecs University of Science, Clinic of Neurology

    Pecs, Ret U2
    Hungary

    Site Not Available

  • Orszagos Idegsebeszeti Tudomanyos Intezet

    Budapest, 1145
    Hungary

    Site Not Available

  • Orszagos Pszichiatriai es Neurologiai Intezet

    Budapest, 1021
    Hungary

    Site Not Available

  • Assaf Harofeh Medical Center

    Beer Yaakov, 70300
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Site Not Available

  • Wolfson Medical Center

    Holon, 58100
    Israel

    Site Not Available

  • Western Galilee Hospital

    Nahariya, 22100
    Israel

    Site Not Available

  • Chaim Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Kaplan Medical Center

    Rechovot, 76100
    Israel

    Site Not Available

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Specjalistyczna Przychodnia Lekarska Medikard

    Padlewskiego 4, Plock 09-402
    Poland

    Site Not Available

  • Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"

    Plac Hallera 5, Warszawa 03-464
    Poland

    Site Not Available

  • Oddzial Neurologii -- Klinika Neurologii ICZMP

    U1. Parzeczewska 35, Zgierz 95-100
    Poland

    Site Not Available

  • NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"

    Bialystok,
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika

    Gdansk, 80-803
    Poland

    Site Not Available

  • WSS im.Kardynala S. Wyszynskiego

    Lublin, 20-718
    Poland

    Site Not Available

  • Instytut Psychiatrii i Neurologii II Oddzial Neurologii

    Warszawa, 02-957
    Poland

    Site Not Available

  • Kazan State Medical University

    Kazan, 420012
    Russian Federation

    Site Not Available

  • City Hospital # 1

    Moscow, 117049
    Russian Federation

    Site Not Available

  • City Hospital # 33

    Moscow,
    Russian Federation

    Site Not Available

  • District Antiepileptic Centre City Clinical Hospital # 71

    Moscow,
    Russian Federation

    Site Not Available

  • Pavlov State Medical University Clinic and Department of Neurology

    St. Petersburg,
    Russian Federation

    Site Not Available

  • Russian Military Medical Academy

    St. Petersburg, 194044
    Russian Federation

    Site Not Available

  • Sunninghill & Kopano Clinical Trials

    Johannesburg, Gauteng 2157
    South Africa

    Site Not Available

  • Wilgers MR & Medical Centre

    Pretoria, Gauteng 0001
    South Africa

    Site Not Available

  • Panorama Medi-Clinic

    Parow, W Cape 7550
    South Africa

    Site Not Available

  • Groote Schuur Hospital

    Cape Town, WC 7925
    South Africa

    Site Not Available

  • Carl Bremer Hospital

    Belville, W Cape, 7531
    South Africa

    Site Not Available

  • Farmovs Parexel

    BleomFontein, Free State, 9300
    South Africa

    Site Not Available

  • Inkosi Albert Luthuli Central Hospital

    Durban, KZ-Natal, 4091
    South Africa

    Site Not Available

  • Johannesburg Hospital

    Johannesburg, Gauteng, 2193
    South Africa

    Site Not Available

  • Triple M Research

    Port Elisabeth, E Cape, 6001
    South Africa

    Site Not Available

  • Hospital Sta. Creu i S. Pau

    Barcelona, 08025
    Spain

    Site Not Available

  • Hospital de Cruces Neurology Department

    Bilbao, 48903
    Spain

    Site Not Available

  • Hosp. Virgen de las Nieves

    Granada, 18014
    Spain

    Site Not Available

  • Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Ruber Internacional de Madrid

    Madrid, 28034
    Spain

    Site Not Available

  • Hosp. de Donostia Neurology Department

    San Sebastian, 20014
    Spain

    Site Not Available

  • Hospital Universitario Lozano Blesa Neurology Service

    Zaragoza, 50009
    Spain

    Site Not Available

  • Psychosomatic Center of Dnepropetr. Regional Clinic

    Dnepropetrovsk, 49616
    Ukraine

    Site Not Available

  • Institute of Neurology, Psychiatry and Narcology of AMS, Ukr

    Kharkov, 31068
    Ukraine

    Site Not Available

  • Kharkov State Medical University

    Kharkov, 31002
    Ukraine

    Site Not Available

  • Epilepsy Center of Municipal Clinical Psychoneurological Hospital

    Kiev, 04080
    Ukraine

    Site Not Available

  • Odessa Regional Clinical Hospital Center for Neurology and Neurosurgery

    Odessa, 65025
    Ukraine

    Site Not Available

  • The James Cook University Hospital

    Middlesbrough, Mersyd TS4 3BY
    United Kingdom

    Site Not Available

  • Fylde Coast Hospital

    Blackpool, FY3 8BP
    United Kingdom

    Site Not Available

  • Western Infirmary (Epilepsy)

    Glasgow, G11 6NT
    United Kingdom

    Site Not Available

  • Royal London Hospital

    London, GT LON E1 1BB
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.