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 332, Study 311, or EAP 401. Doses of perampanel can be adjusted based on clinical judgment.
Other Name: E2007, Fycompa
1. Participants who have completed their participation in Study 332 or Study 311, or who are being rolled over from EAP 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]).
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.
Eisai Medical Information
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