Eisai Clinical Trials

An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects

E2007-J000-341

Study Overview

E2007
perampanel
NCT02427607, EU CTR 2016-004945-10
May 2016 - Sep 2016
Epilepsy
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 ]

  • Males and females (age 12 years and over)

  • Completed

  • Phase 3

  • Japan

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Wechsler RT et al. Long-term safety and efficacy outcomes of adjunctive perampanel: an open-label extension (OLEx) of a Phase III study in patients with drug-resistant primary generalized tonic-clonic (PGTC) seizures in idiopathic generalized epilepsy (IGE). Neurology 2017; Suppl 1. 88.16

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.

Redacted documents are available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR