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The Extended Access Program (EAP) is a managed access programme for Perampanel. The main objective of this EAP is to ensure that patients participating in studies E2007-A001-207, E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time perampanel tablets become commercially available for the treatment of Partial Onset Seizures (POS) in the country in which they reside. This EAP will consist of 2 phases:
Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in previous study. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based on clinical judgment.
Treatment will be prescribed as long as clinically appropriate according to the judgement of the treating physician and the approved Summary of Product Characteristics (SmPC).
The program will complete in a staggered fashion, country by country, as and when perampanel becomes commercially available for the treatment of POS in each country.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perampanel | Drug | Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in Studies 207, 307, or 235. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted based on clinical judgment. A minimum daily dose permitted will be 12 mg per day. Treatment will be prescribed as long as clinically appropriate according to the judgment of the treating physician and the approved summary of Product Characteristics (SmPC). Tablets will be available in strengths of 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. Patients will be instructed to take their perampanel tablets once daily, by mouth, before bedtime, and with food. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Cerebro Y Mente | Mendoza | Mendoza Province | M5519FNF | Argentina | ||
| Hospital General De Agudos José María Ramos Mejia |
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| Buenos Aires |
| C1221ADC |
| Argentina |
| Buenos Aires | Argentina |
| Centro De Estudio Y Tratamiento De La Epilepsia Y Sueno - Cetes S.A. | Córdoba | Argentina |
| Rosario | Argentina |
| San José Guaymallén | Argentina |
| San Miguel de Tucumán | Argentina |
| St Vincent's Hospital Melbourne | Fitzroy | VIC 3065 | Australia |
| Fitzroy | Australia |
| Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre | Heidelberg | VIC 3081 | Australia |
| Royal Melbourne Hospital | Parkville | VIC 3050 | Australia |
| Victoria | Australia |
| Uz Antwerpen | Edegem | 2650 | Belgium |
| Edegem | Belgium |
| Uz Gent | Ghent | 9000 | Belgium |
| Ghent | Belgium |
| Ottignies | Belgium |
| Foothills Medical Center | Calgary | Albert | T2N 2T9 | Canada |
| London Health Sciences Center | London | Ontario | N6A 5A5 | Canada |
| Youthdale Treatment Centers | Toronto | Ontario | M5B 1T9 | Canada |
| Calgary | Canada |
| London, Ontario | Canada |
| Puente Alto | Chile |
| Hospital Dr. Sótero Del Río | Santiago | Chile |
| Santiago | Chile |
| Hospital Base Valdivia Servicio De Neurología | Valdivia | Chile |
| Valdivia | Chile |
| Fakultni Nemocnice U Sv. Anny V Brne | Brno | 656 91 | Czechia |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Ostrava | Czechia |
| Fakultni Nemocnice V Motole | Prague | 150 06 | Czechia |
| Laagri | Estonia |
| West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| Oy Neurodiagnostika Ap | Tallinn | 13419 | Estonia |
| Tallinn Children's Hospital | Tallinn | 13419 | Estonia |
| Tartu University Hospital | Tartu | 51014 | Estonia |
| Vantaa | Finland |
| Greece | Greece |
| Kwai Chung | Hong Kong |
| Budapest | Hungary |
| Barzilai Medical Center | Ashkelon | 78278 | Israel |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Haifa | Israel |
| Edith Wolfson Medical Center | Holon | 58100 | Israel |
| Netanya | Israel |
| Azienda Ospedaliera Universitaria Federico Ii | Naples | 80131 | Italy |
| Naples | Italy |
| Prague | Latvia |
| Childrens Clinical University Hospital | Riga | Lv-1004 | Latvia |
| Riga | Latvia |
| Outpatient Clinic 'Valmieras Veselibas Centrs' | Valmiera | Lv 4201 | Latvia |
| Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics | Kaunas | Lt-50009 | Lithuania |
| Kaunas | Lithuania |
| Klaipeda University Hospital | Klaipėda | Lt-92288 | Lithuania |
| Vilnius University Hospital Santariskes Clinics | Vilnius | Lt-08661 | Lithuania |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Petaling Jaya | Malaysia |
| Haarlem | Netherlands |
| Kempenhaeghe | Heeze | 5591 | Netherlands |
| Stichting Epilepsie Instellingen Nederland | Hoofddorp | 2130 | Netherlands |
| Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku | Gdansk | 80-952 | Poland |
| Gdansk | Poland |
| Albacete | Spain |
| Hospital Universitario San Cecilio | Granada | 18012 | Spain |
| Granada | Spain |
| Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Madrid | Spain |
| Hospital Universitari I Politècnis La Fe Bulevar Sur | Valencia | 46026 | Spain |
| Valencia | Spain |
| Dawan | Taiwan |
| Tainan | Taiwan |
| Taoyuan | Taiwan |
| King Chulalongkorn Memorial Hospital, Chulalongkorn University | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Bangplee | Thailand |
| Maharaj Nakorn Chiang Mai, Chiang Mai University | Chiang Mai | 50200 | Thailand |
| Srinagarind Hospital | Khonkaen | 40002 | Thailand |
| ID | Term |
|---|---|
| C551441 | perampanel |
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