Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

This was an open-label extension (OLE) study for subjects who completed one of the following
double-blind, placebo-controlled, Phase 3 studies: E2007-G000-304 (NCT00699972),
E2007-G000-305 (NCT00699582), and E2007-G000-306 (NCT00700310). This OLE study consisted of
2 phases: an Open-label Treatment Phase (comprised of a 16-week blinded Conversion Period
and a 256-week Maintenance Period) and a Follow-up Phase (4 weeks). During the Conversion
Period, subjects and investigators remained blinded to the treatment received in the
previous DB study. To achieve this, all subjects continued to take 6 tablets of study
medication (2 mg perampanel or matching placebo) or fewer as they were instructed during the
core Double-Blind (DB) study. During the open-label Maintenance Period, subjects were
treated with the perampanel dose that provided the best combination of individual efficacy
and tolerability.

Inclusion Criteria:

Each participant who met the following criteria were enrolled in this study:

1. Who completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and
complied with the inclusion and exclusion criteria for that study (excluding criteria
that are related to seizure occurrences).

2. Provided written informed consent signed by participant or legal guardian prior to
entering the study or undergoing any study procedures (If the written informed
consent was provided by the legal guardian because the participant was unable to do
so, a written or verbal assent from the participant was obtained).

3. Who was considered reliable and willing to be available for the study period and
record seizures and report adverse events them self or have a caregiver who can
record and report the events for them.

4. Females who were either of non-childbearing potential (defined as having undergone
surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or
of childbearing potential. Females of childbearing potential were enrolled only if
they agreed to be abstinent or continue using at least 1 medically acceptable method
of contraception (eg, a double-barrier method [eg, condom + spermicide, condom +
diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the study
period and for 2 months after the last dose of study drug. Women using hormonal
contraceptives were required to use an additional approved method of contraception
(as described previously) continuously throughout the entire study period and for 2
months after the last dose of study drug. (It was not required for male subjects to
use contraceptive measures based on preclinical toxicology data).

5. Continued to be treated with a stable dose of 1 or a maximum of 3 approved
anti-epileptic drugs.

Exclusion Criteria:

Participants who met the following criteria were excluded from the study:

1. Those who, for any reason, discontinued early from the preceding double-blind study.