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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00310388
First received: March 30, 2006
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Retigabine (INN), Ezogabine (USAN)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage change in the monthly seizure rate from the baseline phase to the open-label treatment phase. [ Time Frame: Frequency rates to be determined at end of the open-label treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reports of adverse events [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • Results of vital signs [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • Weight [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • Clinical laboratory evaluations [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • 12-lead ECG [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]
  • Post-void residual bladder ultrasounds [ Time Frame: At selected study visits ] [ Designated as safety issue: Yes ]

Enrollment: 376
Study Start Date: July 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Retigabine (INN), Ezogabine (USAN)
Retigabine (Ezogabine): all subjects
Drug: 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.
Other Names:
  • GW582892X
  • D-23129
  • GKE-841

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310388

  Hide Study Locations
Locations
Australia, New South Wales
Institute of Clniical Neurosciences
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
North Coast Neurology Centre
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5041
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Austin & Repatriation Medical Centre
West Heidelberg, Victoria, Australia, 3081
Belgium
General Hospital Middelheim -- Department of Neurology
Antwerp, Belgium, B-2020
AZ Sint-Jan
Brugge, Belgium, 8000
Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology
Leuven, Belgium, 3000
Centre Neurologique William Lennox
Ottignies, Belgium, 1340
France
Hopital Civil de Steasbourg Clinique Neurologie
Levallois-Perret, France, 92594
Hopital Neurologique Pierre Wertheimer
Lyon, France, 69003
CHU Pontchaillou
Rennes Cedex, France, 35033
Centre Medical de La Teppe
Tain L'Hermitage, 26, France, 26600
Germany
Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen
Erlangen, BY, Germany, 91054
Universitaet Giessen / Marburg Neurologie
Marburg, HE, Germany, 35033
Universitaetsklinik Mainz Neurologische Klinik
Mainz, RP, Germany, 55101
University of Bonn -- Department for Epileptplogy
Bonn, Germany, D-53105
Private Neurologische Paraxis
Muenchen, BY, Germany, 80333
Universitaetslinkum Ulm Poliklinik fuer Neurologie
Ulm, BW, Germany, 89081
Hungary
Pecs University of Science, Clinic of Neurology
Pecs, Ret, Hungary, U2
Orszagos Idegsebeszeti Tudomanyos Intezet
Budapest, Hungary, 1145
Orszagos Pszichiatriai es Neurologiai Intezet
Budapest, Hungary, 1021
Israel
Assaf Harofeh Medical Center
Beer Yaakov, Israel, 70300
Rambam Medical Center
Haifa, Israel, 31096
Wolfson Medical Center
Holon, Israel, 58100
Western Galilee Hospital
Nahariya, Israel, 22100
Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
Kaplan Medical Center
Rechovot, Israel, 76100
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Poland
Specjalistyczna Przychodnia Lekarska Medikard
Padlewskiego 4, Plock, Poland, 09-402
Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"
Plac Hallera 5, Warszawa, Poland, 03-464
Oddzial Neurologii -- Klinika Neurologii ICZMP
U1. Parzeczewska 35, Zgierz, Poland, 95-100
NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"
Bialystok, Poland
Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika
Gdansk, Poland, 80-803
WSS im.Kardynala S. Wyszynskiego
Lublin, Poland, 20-718
Instytut Psychiatrii i Neurologii II Oddzial Neurologii
Warszawa, Poland, 02-957
Russian Federation
Kazan State Medical University
Kazan, Russian Federation, 420012
City Hospital # 1
Moscow, Russian Federation, 117049
District Antiepileptic Centre City Clinical Hospital # 71
Moscow, Russian Federation
City Hospital # 33
Moscow, Russian Federation
Pavlov State Medical University Clinic and Department of Neurology
St. Petersburg, Russian Federation
Russian Military Medical Academy
St. Petersburg, Russian Federation, 194044
South Africa
Sunninghill & Kopano Clinical Trials
Johannesburg, Gauteng, South Africa, 2157
Wilgers MR & Medical Centre
Pretoria, Gauteng, South Africa, 0001
Panorama Medi-Clinic
Parow, W Cape, South Africa, 7550
Groote Schuur Hospital
Cape Town, WC, South Africa, 7925
Carl Bremer Hospital
Belville, W Cape, South Africa, 7531
Farmovs Parexel
BleomFontein, Free State, South Africa, 9300
Inkosi Albert Luthuli Central Hospital
Durban, KZ-Natal, South Africa, 4091
Johannesburg Hospital
Johannesburg, Gauteng, South Africa, 2193
Triple M Research
Port Elisabeth, E Cape, South Africa, 6001
Spain
Hospital Sta. Creu i S. Pau
Barcelona, Spain, 08025
Hospital de Cruces Neurology Department
Bilbao, Spain, 48903
Hosp. Virgen de las Nieves
Granada, Spain, 18014
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hospital Ruber Internacional de Madrid
Madrid, Spain, 28034
Hosp. de Donostia Neurology Department
San Sebastian, Spain, 20014
Hospital Universitario Lozano Blesa Neurology Service
Zaragoza, Spain, 50009
Ukraine
Psychosomatic Center of Dnepropetr. Regional Clinic
Dnepropetrovsk, Ukraine, 49616
Institute of Neurology, Psychiatry and Narcology of AMS, Ukr
Kharkov, Ukraine, 31068
Kharkov State Medical University
Kharkov, Ukraine, 31002
Epilepsy Center of Municipal Clinical Psychoneurological Hospital
Kiev, Ukraine, 04080
Odessa Regional Clinical Hospital Center for Neurology and Neurosurgery
Odessa, Ukraine, 65025
United Kingdom
The James Cook University Hospital
Middlesbrough, Mersyd, United Kingdom, TS4 3BY
Fylde Coast Hospital
Blackpool, United Kingdom, FY3 8BP
Western Infirmary (Epilepsy)
Glasgow, United Kingdom, G11 6NT
Royal London Hospital
London, United Kingdom, GT LON E1 1BB
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00310388     History of Changes
Other Study ID Numbers: VRX-RET-E22-304, EUDRACT No. 2006-000956-42, RTG115097
Study First Received: March 30, 2006
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Partial Seizures
Epilepsy
RTG115097
Complex Partial Seizures
Anticonvulsant
Potassium Channels
Epilepsies, Partial

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
D 23129
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014