Eisai Clinical Trials

A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

E2007-J000-335

Study Overview

E2007
perampanel
NCT01618695, 2020-002109-24, JapicCTI-121906, CTR20131839, jRCT2081211861
May 2012 - May 2020
Epilepsy
1. Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) [Time Frame: Baseline, Week 19]

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

  • Completed

  • Phase 3

  • Australia, China, Japan, Korea, Republic of, Malaysia, Taiwan, Thailand See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Nishida T, Lee SK, Inoue Y, Saeki K, Ishikawa K, Kaneko S. Adjunctive perampanel in partial-onset seizures: Asia-Pacific, randomized phase III study. Acta Neurol Scand. 2018 Apr;137(4):392-399. doi: 10.1111/ane.12883. Epub 2017 Dec 17.

Data Sharing

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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