An Extended Access Program for Perampanel
1 other identifier
expanded_access
N/A
20 countries
70
Brief Summary
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.
Trial Health
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70 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedApril 16, 2020
March 1, 2020
June 4, 2013
April 15, 2020
Conditions
Keywords
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 \[condom plus spermicide, condom plus diaphragm with spermicide\])
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (78)
Fundacion Cerebro Y Mente
Mendoza, Mendoza Province, M5519FNF, Argentina
Hospital General De Agudos José María Ramos Mejia
Buenos Aires, C1221ADC, Argentina
Unknown Facility
Buenos Aires, Argentina
Centro De Estudio Y Tratamiento De La Epilepsia Y Sueno - Cetes S.A.
Córdoba, Argentina
Unknown Facility
Rosario, Argentina
Unknown Facility
San José Guaymallén, Argentina
Unknown Facility
San Miguel de Tucumán, Argentina
St Vincent's Hospital Melbourne
Fitzroy, VIC 3065, Australia
Unknown Facility
Fitzroy, Australia
Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre
Heidelberg, VIC 3081, Australia
Royal Melbourne Hospital
Parkville, VIC 3050, Australia
Unknown Facility
Victoria, Australia
Uz Antwerpen
Edegem, 2650, Belgium
Unknown Facility
Edegem, Belgium
Uz Gent
Ghent, 9000, Belgium
Unknown Facility
Ghent, Belgium
Unknown Facility
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
Unknown Facility
Calgary, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Puente Alto, Chile
Hospital Dr. Sótero Del Río
Santiago, Chile
Unknown Facility
Santiago, Chile
Hospital Base Valdivia Servicio De Neurología
Valdivia, Chile
Unknown Facility
Valdivia, Chile
Fakultni Nemocnice U Sv. Anny V Brne
Brno, 656 91, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Unknown Facility
Ostrava, Czechia
Fakultni Nemocnice V Motole
Prague, 150 06, Czechia
Unknown Facility
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
Unknown Facility
Vantaa, Finland
Unknown Facility
Greece, Greece
Unknown Facility
Kwai Chung, Hong Kong
Unknown Facility
Budapest, Hungary
Barzilai Medical Center
Ashkelon, 78278, Israel
Rambam Medical Center
Haifa, 31096, Israel
Unknown Facility
Haifa, Israel
Edith Wolfson Medical Center
Holon, 58100, Israel
Unknown Facility
Netanya, Israel
Azienda Ospedaliera Universitaria Federico Ii
Napoli, 80131, Italy
Unknown Facility
Napoli, Italy
Unknown Facility
Prague, Latvia
Childrens Clinical University Hospital
Riga, Lv-1004, Latvia
Unknown Facility
Riga, Latvia
Outpatient Clinic 'Valmieras Veselibas Centrs'
Valmiera, Lv 4201, Latvia
Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics
Kaunas, Lt-50009, Lithuania
Unknown Facility
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
Unknown Facility
Petaling Jaya, Malaysia
Unknown Facility
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
Unknown Facility
Gdansk, Poland
Unknown Facility
Albacete, Spain
Hospital Universitario San Cecilio
Granada, 18012, Spain
Unknown Facility
Granada, Spain
Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Unknown Facility
Madrid, Spain
Hospital Universitari I Politècnis La Fe Bulevar Sur
Valencia, 46026, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Dawan, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taoyuan District, Taiwan
King Chulalongkorn Memorial Hospital, Chulalongkorn University
Bangkok, 10330, Thailand
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Unknown Facility
Bangplee, Thailand
Maharaj Nakorn Chiang Mai, Chiang Mai University
Chiang Mai, 50200, Thailand
Srinagarind Hospital
Khonkaen, 40002, Thailand
MeSH Terms
Interventions
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2013
First Posted
June 6, 2013
Last Updated
April 16, 2020
Record last verified: 2020-03