Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial
This study is ongoing, but not recruiting participants.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00310388
First received: March 30, 2006
Last updated: September 13, 2012
Last verified: September 2012
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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:
Genetics Home Reference related topics:
autosomal dominant partial epilepsy with auditory features
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Ezogabine
U.S. FDA Resources
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: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (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:
|
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
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Hide Study LocationsLocations
| 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: | September 13, 2012 |
| 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 May 23, 2013