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

NCT ID: NCT00903786

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-17
• Study Completion Date: 2016-10-31

Brief 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.

Conditions

Refractory Partial Seizures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Perampanel

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.

Group Type: EXPERIMENTAL

perampanel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

E2007; Fycompa

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazunori Saeki

Role: STUDY_DIRECTOR

Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.

Locations

Kitakyushu, Fukuoka, Japan

Kobe, Hyōgo, Japan

Sendai, Miyagi, Japan

Komatsushimachō, Tokushima, Japan

Kodaira, Tokyo, Japan

Kyoto, , Japan

Nagasaki, , Japan

Niigata, , Japan

Shizuoka, , Japan

Countries

Japan

Other Identifiers

E2007-J081-233

Identifier Type: -

Identifier Source: org_study_id