4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures

This is an Open-Label Extension (OLE) study for patients who completed the E2007-A001-206
(NCT00144690) or the E2007-G000-208 (NCT00416195) double-blind, placebo-controlled,
dose-escalation, parallel-group studies.

This study consisted of 3 periods: OLE Titration (12 weeks), OLE Maintenance (424 weeks),
and OLE Follow-up (4 weeks). During the OLE Titration Period, participants were titrated to
their maximum tolerated dose (MTD) of perampanel, up to a maximum of 12 mg/day. The OLE
Maintenance Period began at completion of the OLE Titration Period; participants remained on
the dose achieved at the end of the OLE Titration Period unless dose adjustment for
tolerability reasons was necessary. Participants who either withdrew from the study
prematurely or completed the OLE Maintenance Period returned for a final visit at the end of
the 4-week OLE Follow-up Period.

KEY INCLUSION CRITERIA:

1. Have completed all scheduled visits up to and including Visit 8 in the E2007-A001-206
(NCT00144690) study or Visit 9 of the E2007-G000-208 (NCT00416195) study.

2. Are reliable and willing to make themselves available for the study period and are
able to record seizures and report adverse events themselves or have a caregiver who
can record and report the events.

3. Females of childbearing potential must continue practicing a medically acceptable
method of contraception (e.g., abstinence, a barrier method plus spermicide, or
Intrauterine device (IUD)) and for 8 weeks after the end of the OLE study. Those
women using hormonal contraceptives must also continue using an additional approved
method of contraception (e.g., a barrier method plus spermicide, or IUD).

4. Are between the ages of 18 and 70 years of age, inclusive.

5. Are at least 40 kg (88 lb) of weight.

6. Are currently being treated with a stable dose of one, or a maximum of three licensed
Anti-epileptic drugs (AEDs) and are known to take their medication(s) as directed.

KEY EXCLUSION CRITERIA:

1. Show evidence of clinically significant disease (cardiac, respiratory,
gastrointestinal, renal disease, etc.,) that, in the opinion of the Investigator(s),
could affect the participant's safety or trial conduct.

2. Show evidence of significant active hepatic disease and/or bilirubin greater than 1.5
mg/dL. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and
aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if
they are less than two times the upper limit of normal (ULN).

3. Show evidence of significant active hematological disease. White blood cell (WBC)
count cannot be less than or equal to 2500/microL or an absolute neutrophil count
less than or equal to 1000/microL.

4. Clinically significant ECG abnormality, including prolonged QTc (defined as greater
than or equal to 450 msec).

5. Presence of major active psychiatric disease. Participants taking a stable dose of
selective serotonin reuptake inhibitor (SSRI) antidepressant will be allowed.