An Extended Access Program for Perampanel.
This is an Extended Access Program/ Compassionate Use study for subjects who are currently participating in Eisai 307, or Eisai 235 studies and are willing to participate in the Extended Access / Compassionate Use Program for Perampanel. This study consists of clinic visit every three months to dispense study drug. There are no procedures, no tests, and no labs required by the Extended Access Program. The Clinic visits are set-up to dispense study drug with their treating physician. If the physician determines the patient requires labs, additional tests, or procedures this will be billed and treated as standard of care. If subject requires dose adjustment, physician will follow dosing instructions as per the Investigator and amp;apos;s clinical judgement and the subjects willingness to increase the perampanel doses up to a maxinmum of 12 mg. CRF and amp;apos;s are available for AE and amp;apos;s, SAE and amp;apos;s, Dose Adjustment, and in the event of a pregnancy. This study will be ongoing until the study drug Perampanel is available commercially.
1. Patients who are participating in either Eisai 307, or Eisai 235 studies
and who in the opinion of the treating physician, continue to benefit from
treatment with perampanel.
2. Patients who provide informed consent.
3. 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])