Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

539

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

Conditions
Seizures
Interventions
DRUG

Retigabine

Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase.

DRUG

Retigabine

Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase.

DRUG

Placebo

Oral tablet.

Trial Locations (70)

1021

Natl. Inst. of Psychiatry and Neurology, Budapest

1145

Orszagos Idegsebeszeti Tudomanyos Intezet, Budapest

1340

Centre Neurologique William Lennox, Ottignies

2020

A. Z. Middelheim -- Department of Neurology, Antwerp

2050

Royal Prince Alfred Hospital, Camperdown

2157

Sunninghill & Kopano Clinical Trials, Sunninghill

2193

Johannesburg Hospital, Johannesburg

3000

Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology, Leuven

3050

Royal Melbourne Hospital, Parkville

3084

Austin & Repatriation Medical Centre, West Heidelberg

3168

Monash Medical Centre, Clayton

4091

Inkosi Albert Luthuli Central Hospital, Durban

4558

North Coast Neurology Centre, Maroochydore

6001

Triple M Research, Port Elizabeth

7531

Carl Bremer Hospital, Belville

7550

Panorama Medi-Clinic, Cape Town

7925

Groote Schuur Hospital, Cape Town

8000

AZ Sint-Jan, Bruges

9300

University of the Free State, Bloemfontein

18013

Hosp. Virgen de las Nieves, Granada

20014

Hosp de Donostia, Donostia / San Sebastian

20817

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

22100

Western Galilee Hospital, Nahariya

28034

Hospital Ruber Internacional de Madrid, Madrid

31096

Rambam Medical Center, Haifa

35033

CHU Pontchaillou, Rennes

48903

Hospital de Cruces, Bilbao

49616

Psychosomatic Center of Dnepropetr. Regional Clinic, Dnipro

50009

Hosp. Clinico Univ. Lozano Blesa, Zaragoza

52621

Chaim Sheba Medical Center, Ramat Gan

58100

Wolfson Medical Center, Holon

61022

Kharkiv State Medical University, Kharkiv

61068

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

64239

Tel-Aviv Sourasky Medical Center, Tel Aviv

65025

Odessa Regional Clinical Hospital, Odesa

69003

Hopital Neurologique Pierre Wertheimer, Lyon

70300

Assaf Harofeh Medical Center, Beer Yaakov

75230

Neurological Clinic-Texas, Dallas

76100

Kaplan Medical Center, Rehovot

78306

Barzilai Medical Center, Ashkelon

117049

City Hospital # 1, Moscow

119021

Clinic of Nervous Diseases of Sechenov's Moscow Med. Academy, Moscow

121374

District Antiepileptic Centre City Clinical Hospital # 71, Moscow

194044

Military Medical Academy n.a. S.M.Kirov, Saint Petersburg

197022

St.Petersburg State Medical University n.a. I.P.Pavlov, Saint Petersburg

420048

Interregional Clinical Diagnostic Centre, Kazan'

67 67091

Hopital Civil de Strasbourg, Strasbourg

26 26600

Centre Medical de La Teppe, Tain-l'Hermitage

D-53105

University of Bonn -- Department for Epileptplogy, Bonn

BY 91054

Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen, Erlangen

NI 37075

Georg-August-Universitaet Goettingen, Göttingen

RP 55101

Universitaetsklinik Mainz Neurologische Klinik, Mainz

HE 35033

Universitaet Giessen / Marburg Neurologie, Marburg

BY 80333

Theatinerstrasse 44, Munich

BW 89081

Universitaetsklinikum Ulm, Ulm

09-402

Specjalistyczna Przychodnia Lekarska Medikard, Padlewskiego 4

15-420

"NZOZ Przychodnia Internistyczno - Stomatologiczna Kendron", Bialystok

80-803

Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika, Gdansk

40-752

Katedra i Klinika Neurologii Slaskiej Akademii Medycznej, Katowice

20-718

WSS im.Kardynala S. Wyszynskiego, Lublin

02-957

Instytut Psychiatrii i Neurologii II Oddzial Neurologii, Warsaw

03-464

"Prywatna Wielospecjalistyczna Lecznica Medyczna Zycie", Warsaw

0041

Wilgers MR & Medical Centre, Pretoria

08025

Hospital de La Santa Creu i Sant Pau, Barcelona

04080

Epilepsy Center of Municipal Clinical Psychoneurological Hospital, Kiev

T&W TS4 3BW

The James Cook University Hospital, Middlesbrough

LANARK FY3 8BP

Fylde Coast Hospital, Blackpool

G11 6NT

Western Infirmary (Epilepsy), Glasgow

L9 7LJ

Walton Centre for Neurology & Neurosurgery, Liverpool

GT LON E1 1BB

Royal London Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bausch Health Americas, Inc.

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY