Eisai Clinical Trials

A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

E2007-G000-305

Study Overview

E2007
perampanel
NCT00699582, 2007-006168-31
May 2008 - Jan 2011
Epilepsy
1. Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) [Time Frame: Baseline (Pre-randomization) through Week 19]

  • Males and females 12 Years and older (Child, Adult, Older Adult)

  • Completed

  • Phase 3

  • Austria, Belgium, Finland, France, Germany, India, Israel, Italy, Netherlands, Russian Federation, South Africa, Sweden, United Kingdom, United States See more

Clinical Trial Documents

Clinical Study Report Synopsis

No download available

Plain Language Protocol Synopsis (PLPS)

No download available

Plain Language Summary of Results (PLS)

No download available

Publication reference citation

Maguire M. Response to “Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?”. Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.

French JA, Gil-Nagel A, Malerba S, Kramer L, Kumar D, Bagiella E. Time to prerandomization monthly seizure count in perampanel trials: A novel epilepsy endpoint. Neurology. 2015 May 19;84(20):2014-20. doi: 10.1212/WNL.0000000000001585. Epub 2015 Apr 15.

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

CSDR Sharing is available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR