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: - Screening: The patient will start the program once the Screening assessments are completed and the patient is qualified for participation. - Treatment: Additional assessments, physical examinations, and dosage changes will be clinically determined by the treating physician. 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.
Drug: Perampanel
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.
Other Name: E2007
Inclusion Criteria:
- Patients who are participating in either Study 207, Study 307, or Study 235 and who in
the opinion of the treating physician, continue to benefit from treatment with
perampanel (revised per Amendment 01)
- Patients who provide informed consent where applicable per local requirements.
- Female patients of childbearing potential must agree for the duration of the program
and for a period of at least 1 month following last dose of perampanel to be abstinent
or to commit to the consistent and correct use of a medically acceptable method of
birth control (e.g., a double-barrier method [condom plus spermicide, condom plus
diaphragm with spermicide])
Exclusion Criteria:
- Patients residing in countries where perampanel is commercially available for the
treatment of POS
- Female patients who are lactating, pregnant, or planning to become pregnant
Fundacion Cerebro Y Mente
Mendoza, Provincia De Mendoza, Argentina
Hospital General De Agudos José María Ramos Mejia
Buenos Aires, Argentina
Buenos Aires, Argentina
Centro De Estudio Y Tratamiento De La Epilepsia Y Sueno - Cetes S.A.
Cordoba, Argentina
Rosario, Argentina
San José Guaymallén, Argentina
San Miguel de Tucumán, Argentina
St Vincent's Hospital Melbourne
Fitzroy, Australia
Fitzroy, Australia
Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre
Heidelberg, Australia
Royal Melbourne Hospital
Parkville, Australia
Victoria, Australia
Uz Antwerpen
Edegem, Belgium
Edegem, Belgium
Gent, Belgium
Uz Gent
Ghent, Belgium
Ottignies, Belgium
Foothills Medical Center
Calgary, Albert, Canada
London Health Sciences Center
London, Ontario, Canada
Youthdale Treatment Centers
Toronto, Ontario, 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, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Kralove, Czechia
Ostrava, Czechia
Fakultni Nemocnice V Motole
Prague, Czechia
Laagri, Estonia
West Tallinn Central Hospital
Tallinn, Estonia
Oy Neurodiagnostika Ap
Tallinn, Estonia
Tallinn Children's Hospital
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
Vantaa, Finland
Greece, Greece
Kwai Chung, Hong Kong
Budapest, Hungary
Barzilai Medical Center
Ashkelon, Israel
Rambam Medical Center
Haifa, Israel
Haifa, Israel
Edith Wolfson Medical Center
Holon, Israel
Netanya, Israel
Azienda Ospedaliera Universitaria Federico Ii
Napoli, Italy
Napoli, Italy
Prague, Latvia
Childrens Clinical University Hospital
Riga, Latvia
Riga, Latvia
Outpatient Clinic 'Valmieras Veselibas Centrs'
Valmiera, Latvia
Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics
Kaunas, Lithuania
Kaunas, Lithuania
Klaipeda University Hospital
Klaipeda, Lithuania
Vilnius University Hospital Santariskes Clinics
Vilnius, Lithuania
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Petaling Jaya, Malaysia
Haarlem, Netherlands
Kempenhaeghe
Heeze, Netherlands
Stichting Epilepsie Instellingen Nederland
Hoofddorp, Netherlands
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku
Gdansk, Poland
Gdansk, Poland
Albacete, Spain
Hospital Universitario San Cecilio
Granada, Spain
Granada, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Madrid, Spain
Hospital Universitari I Politècnis La Fe Bulevar Sur
Valencia, Spain
Valencia, Spain
Tainan, Taiwan
Taiwan, Taiwan
Taoyuan, Taiwan
King Chulalongkorn Memorial Hospital, Chulalongkorn University
Bangkok, Thailand
Phramongkutklao Hospital
Bangkok, Thailand
Bangplee, Thailand
Maharaj Nakorn Chiang Mai, Chiang Mai University
Chiang Mai, Thailand
Srinagarind Hospital
Khonkaen, Thailand
Karen Searle, PhD
Study Director
Eisai Limited