Evaluation of the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Completed · Phase 3

Conditions studied: Epilepsy

In brief

The purpose of this study was 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.

Key facts

Study ID

NCT00735397

Run by

Eisai Inc.

People needed

1218

Starts

2008-10-01

Expected to finish

2014-09-01

Last updated by the study team

2016-03-14

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each participant who met the following criteria were enrolled in this study:
• Who completed Visit 8 of study E2007-G000-304, E2007-G000-305, or E2007-G000-306 and complied with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
• Provided written informed consent signed by participant or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent was provided by the legal guardian because the participant was unable to do so, a written or verbal assent from the participant was obtained).
• Who was considered reliable and willing to be available for the study period and record seizures and report adverse events them self or have a caregiver who can record and report the events for them.
• Females who were either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. Females of childbearing potential were enrolled only if they agreed 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 study period and for 2 months after the last dose of study drug. Women using hormonal contraceptives were required to use an additional approved method of contraception (as described previously) continuously throughout the entire study period and for 2 months after the last dose of study drug. (It was not required for male subjects to use contraceptive measures based on preclinical toxicology data).
• Continued to be treated with a stable dose of 1 or a maximum of 3 approved anti-epileptic drugs.

You may not qualify if…

• Participants who met the following criteria were excluded from the study:
• Those who, for any reason, discontinued early from the preceding double-blind study.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Fresno, California, United States
• Study site — San Francisco, California, United States
• Study site — Ventura, California, United States
• Study site — Denver, Colorado, United States
• Study site — Fort Collins, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gulf Breeze, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Suwanee, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Ames, Iowa, United States
• Study site — Lexington, Kentucky, United States
• Study site — Houma, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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