A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)

• Status: Completed
• Trial end date: 2016-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Anticonvulsants

Criteria

Inclusion criteria:

1. Patients who consent to the study entry on their free will before starting any trial-related activities.

2. Patients who participated in Study 231 and completed the required evaluation period (10 weeks).

3. Patients who are certainly and voluntarily able to participate in this study and record their seizures by themselves or have family members or caregivers (or nurses, if hospitalized) record the seizures. Patients who wish to continue perampanel treatment and necessitate receiving the long- term administration judged by the investigator or sub-investigator.

Exclusion criteria:

1. Pregnant or lactating women, women of child-bearing potential, women willing to become pregnant.

2. Patients who are ineligible judged by the investigator or sub investigator in light of medical history or complication at enrollment in treatment period.

3. Patients who operate heavy equipment or drive should not be recruited into the study.

4. Patients who are ineligible for study entry judged by the investigator or sub-investigator.