The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time that the appropriate formulation of perampanel becomes commercially available in the country in which they reside or until no participants remain in the EAP.
Drug: Perampanel
Perampanel will be available in 2-milligrams (mg), 4-mg and 8-mg tablets and as 0.5 milligram per milliliter (mg/mL) oral suspension. Participants will start this EAP with the dose that they were receiving at the end of their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401. Doses of perampanel can be adjusted based on clinical judgment.
Other Name: E2007, Fycompa
Inclusion criteria:
1. Participants who have completed their participation in Study E2007-G000-332, Study
E2007-G000-311, E2007-G000-238, E2007-G000-338, or who are being rolled over from EAP
E2007-G000-401 and, who in the opinion of the treating physician, continue to
demonstrate a positive benefit-to-risk ratio from treatment with perampanel.
2. Participants who provide informed consent where applicable per local requirements.
3. Female participants 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 (example, a double-barrier method [condom plus spermicide,
condom plus diaphragm with spermicide]).
Exclusion criteria:
1. Participants who reside in countries where the appropriate formulation of perampanel
is commercially available.
2. Female participants who are nursing, pregnant, or planning to become pregnant.
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, Belgium
Centre Neurologique William Lennox
Ottignies, Belgium
Hospital Padre Hurtado
Santiago, Chile
Oy Neurodiagnostika Ap
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet
Budapest, Hungary
Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza
Budapest, Hungary
Országos Idegsebészeti Tudományos Intézet
Budapest, Hungary
Rajna és Fiai Kereskedelmi és Szolgáltató Kft.
Budapest, Hungary
Servus Salvus Egeszsegugyi Szolgaltato Kft.
Budapest, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
Miskolc, Hungary
Pécsi Tudományegyetem
Pécs, Hungary
Childrens University Hospital
Riga, Latvia
Klaipeda University Hospital
Klaipeda, Lithuania
Uniwersyteckie Centrum Kliniczne - PPDS
Gdansk, Poland
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce, Poland
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan, Poland
Hospital Sant Joan de Deu
Esplugues de Llobregat, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario Virgen del Rocio -
Sevilla, Spain
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