Overview

This trial is active, not recruiting.

Condition refractory partial seizures
Treatment perampanel
Phase phase 2
Sponsor Eisai Co., Ltd.
Start date June 2009
End date September 2016
Trial size 30 participants
Trial identifier NCT00903786, E2007-J081-233

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
perampanel
Patients will receive the same oral dosage (2 mg up to 12 mg once daily before bedtime) as used in the maintenance period of Study 231.

Primary Outcomes

Measure
Number of patients with adverse events as a measure of safety
time frame: 4 weeks, 8 weeks, 16 weeks and every 12 weeks till approval

Secondary Outcomes

Measure
Evaluation of patient diaries for seizures
time frame: 4 weeks, 8 weeks, 16 weeks and every 12 weeks till approval

Eligibility Criteria

Male or female participants from 20 years up to 64 years old.

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.

Additional Information

Official title A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Eisai Inc..