Overview

This trial is active, not recruiting.

Condition epilepsy
Treatments perampanel, placebo
Phase phase 3
Sponsor Eisai Inc.
Start date October 2008
End date September 2014
Trial size 1218 participants
Trial identifier NCT00735397, E2007-G000-307

Summary

The purpose of this study is to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
2 mg/day perampanel
perampanel
2 mg/day, oral administration.
(Experimental)
4 mg/day perampanel
perampanel
4 mg/day, oral administration.
(Experimental)
6 mg/day perampanel
perampanel
6 mg/day, oral administration.
(Experimental)
8 mg/day perampanel
perampanel
8 mg/day, oral administration.
(Experimental)
10 mg/day perampanel
perampanel
10 mg/day, oral administration.
(Experimental)
12 mg/day perampanel
perampanel
12 mg/day, oral administration.
(Placebo Comparator)
Matching Placebo
placebo
Subjects will receive matching placebo tablets.

Primary Outcomes

Measure
Primary efficacy will be assessed by seizure counts (using subject's diaries) documenting the percent change in seizure frequency per 28 days.
time frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts between visits. After 16 wks, they will be done every 12 wks w/interim telephone contacts in between.

Secondary Outcomes

Measure
Secondary efficacy measures will evaluate the delayed treatment effect by summarizing previous endpoints over the open-label treatment phase relative to the pre-randomization phase of the double-blind study.
time frame: Assessments will be done every 4 wks during the first 16 wks w/interim telephone contacts. After 16 weeks, they will be done every 12 wks w/interim telephone contacts in between.

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: Each subject must meet all of the following criteria to be enrolled in this study: 1. Have completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and shown compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences). 2. Provide written informed consent signed by subject 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 subject is unable to do so, a written or verbal assent from the subject must also be obtained). 3. Be considered reliable and willing to be available for the study period and able to record seizures and report adverse events them self or have a caregiver who can record and report the events for them. 4. Females should be either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. For females of childbearing potential, they must agree to be abstinent or continue using at least 1 medically acceptable method of contraception (eg, a double-barrier method [eg, condom + spermicide, condom + diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the entire study period and for 2 months after the last dose of study drug. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (as described previously) throughout the entire study period and for 2 months after the last dose of study drug. (It is not required for male subjects to use contraceptive measures based on preclinical toxicology data). 5. Continue to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs. Exclusion Criteria: Subjects who meet the following criteria will be excluded from the study: 1. Those who, for any reason, discontinued early from the preceding double-blind study.

Additional Information

Official title An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Eisai Inc..