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

Eisai

Status and phase: Completed; Phase 2

Conditions: Refractory Partial Seizures

Treatments: Drug: perampanel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00903786

E2007-J081-233

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Perampanel

Experimental group

Description:

Participants were treated with the perampanel dose that was administered in maintenance period of Study E2007-J081-231 (Study 231) \[NCT00849212\]. In some instances, a 1-step down-titration from the viewpoint of safety and up-titration to the maintenance dose of Study 231 was allowed. In general, 1 to 6 tablets of perampanel was administered orally as a 2-milligram (mg) tablet (2 mg to 12 mg) once daily before bedtime (under fed conditions as much as possible). The investigator, or subinvestigator, was allowed to complete the treatment by tapering the study drug after end of treatment or discontinuation (Follow-up Period), as appropriate. The taper period was 4 weeks at the longest.

Treatment:

Drug: perampanel