Overview

This trial is active, not recruiting.

Condition epilepsy
Treatment perampanel
Phase phase 3
Sponsor Eisai Co., Ltd.
Start date May 2015
End date September 2016
Trial size 1 participant
Trial identifier NCT02427607, E2007-J000-341

Summary

To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. This study will be continued until perampanel is commercially available.

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
Perampanel 2 mg tablets. Doses of perampanel can be adjusted based on clinical judgment. A minimum perampanel dose of 2 mg per day is required to continue in the study. The maximum daily dose of perampanel permitted will be 12 mg per day.

Primary Outcomes

Measure
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: From signing of informed consent until perampanel is commercially available or up to 1.5 years

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria 1. Participants participating in the designated perampanel study as below, and who in the opinion of the investigator continue to benefit from treatment with perampanel Designated perampanel study: E2007-G000-332 (NCT01393743) (with at least 52 weeks of total exposure to perampanel). 2. Provide written informed consent/assent signed by participant or legal guardian prior to entering the study or undergoing any study procedures. If the written informed consent is provided by the legal guardian because the participant is unable to do so, a written or verbal assent from the participant must also be obtained. 3. Female participants of childbearing potential must agree for the duration of the study and for a period of at least 1 month following the last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (eg, a double-barrier method [condom plus spermicide, condom plus diaphragm with spermicide]). Exclusion Criteria 1. Participants residing in countries where perampanel is commercially available with respect to the indication or formulation of the designated perampanel study. 2. Female participants who are nursing, pregnant, or planning to become pregnant.

Additional Information

Official title An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Eisai Inc..