Clinical trial NCT01871233: An Extended Access Program for Perampanel
Official title: An Extended Access Program for Perampanel
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Partial Onset Seizures
Keywords: anti-epileptic drug
Extended Access Program
partial onset seizures
Perampanel
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-06
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mendoza
country: Argentina
facility: Fundacion Cerebro Y Mente
state: Provincia De Mendoza
city: Buenos Aires
country: Argentina
facility: Hospital General De Agudos José María Ramos Mejia
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
facility: Centro De Estudio Y Tratamiento De La Epilepsia Y Sueno - Cetes S.A.
city: Rosario
country: Argentina
city: San José Guaymallén
country: Argentina
city: San Miguel de Tucumán
country: Argentina
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
city: Fitzroy
country: Australia
city: Heidelberg
country: Australia
facility: Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
city: Victoria
country: Australia
city: Edegem
country: Belgium
facility: Uz Antwerpen
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Ghent
country: Belgium
facility: Uz Gent
city: Ottignies
country: Belgium
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Albert
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Youthdale Treatment Centers
state: Ontario
city: Calgary
country: Canada
city: London, Ontario
country: Canada
city: Puente Alto
country: Chile
city: Santiago
country: Chile
facility: Hospital Dr. Sótero Del Río
city: Santiago
country: Chile
city: Valdivia
country: Chile
facility: Hospital Base Valdivia Servicio De Neurología
city: Valdivia
country: Chile
city: Brno
country: Czechia
facility: Fakultni Nemocnice U Sv. Anny V Brne
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Ostrava
country: Czechia
city: Prague
country: Czechia
facility: Fakultni Nemocnice V Motole
city: Laagri
country: Estonia
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: Oy Neurodiagnostika Ap
city: Tallinn
country: Estonia
facility: Tallinn Children's Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Vantaa
country: Finland
city: Greece
country: Greece
city: Kwai Chung
country: Hong Kong
city: Budapest
country: Hungary
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Netanya
country: Israel
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico Ii
city: Napoli
country: Italy
city: Prague
country: Latvia
city: Riga
country: Latvia
facility: Childrens Clinical University Hospital
city: Riga
country: Latvia
city: Valmiera
country: Latvia
facility: Outpatient Clinic 'Valmieras Veselibas Centrs'
city: Kaunas
country: Lithuania
facility: Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskes Clinics
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Petaling Jaya
country: Malaysia
city: Haarlem
country: Netherlands
city: Heeze
country: Netherlands
facility: Kempenhaeghe
city: Hoofddorp
country: Netherlands
facility: Stichting Epilepsie Instellingen Nederland
city: Gdansk
country: Poland
facility: Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku
city: Gdansk
country: Poland
city: Albacete
country: Spain
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Granada
country: Spain
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
city: Valencia
country: Spain
facility: Hospital Universitari I Politècnis La Fe Bulevar Sur
city: Valencia
country: Spain
city: Tainan
country: Taiwan
city: Taiwan
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital, Chulalongkorn University
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangplee
country: Thailand
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai, Chiang Mai University
city: Khonkaen
country: Thailand
facility: Srinagarind Hospital
Study officials:
References: