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

Condition(s) targeted: Epilepsies, Partial

Intervention: Retigabine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Valeant Pharmaceuticals North America

The purpose of this 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 VRX-RET-E22-302 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

Official title: A Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-Onset Seizures (Extension of Study VRX-RET-E22-302)

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

Percentage change in the monthly seizure rate from the baseline phase to the open-label treatment phase.

Vital signs

Weight

Clinical Lab Evaluations (blood chemistry, hematology, and urinalysis)

12-lead ECGs

Physical and neurological examinations

Evaluations of adverse events.

American Urological Association Symptom Index

Post-void residual bladder ultrasound

Secondary outcome: Proportion of responders (patients experiencing at least a 50% reduction in seizure frequency) from baseline to the open-label treatment phase.

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

AZ Sint-Jan, Brugge 8000, Belgium; Not yet recruiting
Michel Van Zandijcke, Phone: 32-50-452370
Michel Van Zandijcke, Principal Investigator

Centre Neurologique William Lennox, Ottignies 1340, Belgium; Not yet recruiting
Germaine Marie Van Rijckevorsel, MD, Phone: 32-10-430211, Email: vanrijckevorsel@nops.ucl.ac.be
Germaine Marie Van Rijckevorsel, MD, Principal Investigator

General Hospital Middelheim -- Department of Neurology, Antwerp B-2020, Belgium; Not yet recruiting
Peter P De Deyn, MD, Phone: 32 3 280 31 11, Ext: 132
Peter P De Deyn, MD, Principal Investigator

Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology, Leuven 3000, Belgium; Not yet recruiting
Wim Van Paesschen, Prof., Email: wim.vanpaesschen@uz.kuleuve
Wim Van Paesschen, Prof., Principal Investigator

University of Bonn -- Department for Epileptplogy, Bonn D-53105, Germany; Not yet recruiting
Christian E Elger, Professor, Phone: 49 228 2875728, Email: christian.elger@ukb.uni-bonn.de
Christian E Elger, Professor, Principal Investigator

Orszagos Idegsebeszeti Tudomanyos Intezet, Budapest 1145, Hungary; Not yet recruiting
Andras Solyom, Phone: 36-1-2512999, Email: solyand@mailer.oiti.hu
Andras Solyom, Principal Investigator

Orszagos Pszichiatriai es Neurologiai Intezet, Budapest 1021, Hungary; Not yet recruiting
Peter Halasz, Phone: 36-1-3915300
Peter Halasz, Principal Investigator

Assaf Harofeh Medical Center, Beer Yaakov 70300, Israel; Not yet recruiting
Revital Gandelman-Marton, Phone: 972-8-9779755
Revital Gandelman-Marton, Principal Investigator

Chaim Sheba Medical Center, Ramat Gan 52621, Israel; Not yet recruiting
Ilan Blatt, Phone: 972-3-5302340
Ilan Blatt, Principal Investigator

Kaplan Medical Center, Rechovot 76100, Israel; Not yet recruiting
Anda Eilam, Phone: 972-8-9441228
Anda Eilam, Principal Investigator

Rambam Medical Center, Haifa 31096, Israel; Not yet recruiting
Yitzhak Schiller, Phone: 972-4-8542830
Yitzhak Schiller, Principal Investigator

Tel-Aviv Sourasky Medical Center, Tel Aviv 64239, Israel; Not yet recruiting
Miri Neufeld, Phone: 972-3-6973418
Miri Neufeld, Principal Investigator

Western Galilee Hospital, Nahariya 22100, Israel; Not yet recruiting
Bella Gross, Phone: 972-4-9107790
Bella Gross, Principal Investigator

Instytut Psychiatrii i Neurologii II Oddzial Neurologii, Warszawa 02-957, Poland; Not yet recruiting
Anna Czlonkowska, Phone: 48-22-8427683
Anna Czlonkowska, Principal Investigator

Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika, Gdansk 80-803, Poland; Not yet recruiting
Waldemar Fryze, Phone: 48-58-3023031, Ext: 174
Waldemar Fryze, Principal Investigator

WSS im.Kardynala S. Wyszynskiego, Lublin 20-718, Poland; Not yet recruiting
Jacek Gawlowicz, Phone: 48-81-5374555
Jacek Gawlowicz, Principal Investigator

NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron", Bialystok, Poland; Not yet recruiting
Jan Kochanowicz, Phone: 48-85-7455522
Jan Kochanowicz, Principal Investigator

City Hospital # 1, Moscow 117049, Russian Federation; Not yet recruiting
Alla Guekht, Phone: 7-095-236-92-28, Email: 1575.g23@g23.relcom.ru
Alla Guekht, Principal Investigator

City Hospital # 33, Moscow, Russian Federation; Not yet recruiting
Valery Golubev, Phone: 7-095-248-63-64
Valery Golubev, Principal Investigator

District Antiepileptic Centre City Clinical Hospital # 71, Moscow, Russian Federation; Not yet recruiting
Gagik Avakyan, Phone: 7-095-236-96-32, Email: g.avakian@rambler.ru
Gagik Avakian, Principal Investigator

Kazan State Medical University, Kazan 420012, Russian Federation; Not yet recruiting
Eduard Yakupov, Phone: 7-843-236-09-12
Eduard Yakupov, Principal Investigator

Pavlov State Medical University Clinic and Department of Neurology, St. Petersburg, Russian Federation; Not yet recruiting
Alexander Skoromets, Phone: 7-812-238-71-83
Alexander Skoromets, Principal Investigator

Russian Military Medical Academy, St. Petersburg 194044, Russian Federation; Not yet recruiting
Miroslav Odinak, Phone: 7-812-542-34-20
Miroslav Odinak, Principal Investigator

Fundacion Jimenez Diaz, Madrid 28040, Spain; Not yet recruiting
Jose M Serratosa, Phone: 34-91-5504854
Jose M Serratosa, Principal Investigator

Hosp. Virgen de las Nieves, Granada 18014, Spain; Not yet recruiting
Juan Carlos Sanchez Alvarez, Phone: 34-95-8021565
Juan Carlos Sanchez, Principal Investigator

Hospital Ruber Internacional de Madrid, Madrid 28034, Spain; Not yet recruiting
Antonio Gil Nagel Rein, Phone: 34-91-3875250
Antonio Gil Nagel Rein, Principal Investigator

Hospital Sta. Creu i S. Pau, Barcelona 08025, Spain; Not yet recruiting
Antonio Escartin, Phone: 34-93-2919000
Antonio Escartin, Principal Investigator

Epilepsy Center of Municipal Clinical Psychoneurological Hospital, Kiev 04080, Ukraine; Not yet recruiting
Sergiy Kharchuk, Phone: 380-44-4682127
Sergiy Kharchuk, Principal Investigator

Institute of Neurology, Psychiatry and Narcology of AMS, Ukr, Kharkov 31068, Ukraine; Not yet recruiting
Andriy Dubenko, Phone: 380-57-7382181, Email: adneuro@mail.ru
Andriy Dubenko, Principal Investigator

Kharkov State Medical University, Kharkov 31002, Ukraine; Not yet recruiting
Iryna Grygorova, Phone: 380-57-7004021
Iryna Grygorova, Principal Investigator

Psychosomatic Center of Dnepropetr. Regional Clinic, Dnepropetrovsk 49616, Ukraine; Not yet recruiting
Svitlana Moroz, Phone: 380-562-471716, Email: pso@a-teleport.com
Svitlana Moroz, Principal Investigator

Fylde Coast Hospital, Blackpool FY3 8BP, United Kingdom; Not yet recruiting
Bernard Boothman, Phone: 44-1378-123154
Bernard Boothman, Principal Investigator

Royal London Hospital, London GT LON E1 1BB, United Kingdom; Not yet recruiting
Oliver Cockerell, Phone: 44-2076-007748
Oliver Cockerell, Principal Investigator

Western Infirmary (Epilepsy), Glasgow G11 6NT, United Kingdom; Not yet recruiting
Martin Brodie, Phone: 44-1412-111904
Martin Brodie, Principal Investigator

CHU Pontchaillou, Rennes Cedex, 35 35033, France; Not yet recruiting
Arnaud Biraben, Phone: 33-2-99284162
Arnaud Biraben, Principal Investigator

Hopital Neurologique Pierre Wertheimer, Lyon, 69 69003, France; Not yet recruiting
Philippe Ryvlin, Phone: 33-4-72357044, Email: ryvlin@cermep.fr
Philippe Ryvlin, Principal Investigator

Sunninghill & Kopano Clinical Trials, Johannesburg, Gauteng 2157, South Africa; Not yet recruiting
D Lurie, Phone: 27-11-8061866, Email: dlurie@doctors.netcare.co.za
D Lurie, Principal Investigator

Wilgers MR & Medical Centre, Pretoria, Gauteng 0001, South Africa; Not yet recruiting
Chris Retief, Phone: 27-12-8071218
Chris Retief, Principal Investigator

Universitaet Giessen / Marburg Neurologie, Marburg, HE 35033, Germany; Not yet recruiting
Felix Rosenow, Phone: 49-642-12865200
Felix Rosenow, Principal Investigator

The James Cook University Hospital, Middlesbrough, MERSYD TS4 3BY, United Kingdom; Not yet recruiting
Paul McKee, Phone: 44 1642 854208, Email: paul.mckee@stees.nhs.uk
Paul McKee, Principal Investigator

Institute of Clniical Neurosciences, Camperdown, New South Wales 2050, Australia; Not yet recruiting
Armin Mohamed, MD, Phone: (+612) 95157565, Email: arminm@icn.usyd.edu.au
Armin Mohamed, MD, Principal Investigator

Specjalistyczna Przychodnia Lekarska Medikard, Padlewskiego 4, Plock 09-402, Poland; Not yet recruiting
Magdalena Kwiatkowska, MD, Phone: +48 (24) 267-75-73
Magdalena Kwiatkowska, MD, Principal Investigator

North Coast Neurology Centre, Maroochydore, Queensland 4558, Australia; Recruiting
Graham Schapel, Phone: 61-7-54431143
Graham Schapel, Principal Investigator

Universitaetsklinik Mainz Neurologische Klinik, Mainz, RP 55101, Germany; Not yet recruiting
Konrad Werhahn, Phone: 49-6131-175275, Email: werhahn@uni-mainz.de
Konrad Werhahn, Principal Investigator

Pecs University of Science, Clinic of Neurology, Pecs, Ret U2, Hungary; Not yet recruiting
Samuel Komoly, MD, Phone: 36-72-535-910
Samuel Komoly, MD, Principal Investigator

Flinders Medical Centre, Bedford Park, South Australia 5041, Australia; Not yet recruiting
Joe Frasca, Phone: 61-8-82045781
Joe Frasca, Principal Investigator

Austin & Repatriation Medical Centre, West Heidelberg, Victoria 3081, Australia; Not yet recruiting
Sam Berkovic, Phone: 61-3-94962330
Sam Berkovic, Principal Investigator

Royal Melbourne Hospital, Parkville, Victoria 3050, Australia; Not yet recruiting
Zelko Matkovic, Phone: 61-3-83443260
Zelko Matkovic, Principal Investigator

Panorama Medi-Clinic, Parow, W Cape 7550, South Africa; Not yet recruiting
Frans H Badenhorst, Phone: 27-21-9304493, Email: Henk@iafrica.com
Frans H Badenhorst, Principal Investigator

Groote Schuur Hospital, Cape Town, WC 7925, South Africa; Not yet recruiting
E Lee Pan, Phone: 27-21-4043201, Email: eleepan@uctgsh1.uct.ac.za
E Lee Pan, Principal Investigator

Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie", Plac Hallera 5, Warszawa 03-464, Poland; Not yet recruiting
Zygmunt Jamrozik, MD, Phone: 48-(22)-6190404
Zygmunt Jamrozik, MD, Principal Investigator

Oddzial Neurologii -- Klinika Neurologii ICZMP, U1. Parzeczewska 35, Zgierz 95-100, Poland; Not yet recruiting
Andrzej Bogucki, MD, Phone: +48 42 71 44 385
Andrzej Bogucki, MD, Principal Investigator

Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen, Erlangen, by 91054, Germany; Not yet recruiting
Hermann Stefan, Phone: 49-931-18534541
Hermann Stefan, Principal Investigator

Starting date: July 2006
Last updated: November 15, 2006