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
- 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])
- 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
Eisai Eisai Medical Information
Karen Searle, PhD
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