Overview

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

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine the safety of perampanel given as adjunctive, long-term treatment in patients with refractory partial onset seizures.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eisai Inc.
Criteria
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.