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

Eisai Clinical Trials

Protocol # E2007-J000-341

Study Overview

Study Compound: E2007

Drug Name: perampanel

Registry #: NCT02427607, 2016-004945-10

Trial Period: May 2015 - Nov 2016

Indication: Epilepsy

Primary Endpoint:
1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel [ Time Frame: From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months]

Population
Males and females 12 Years and older (Child, Adult, Older Adult)
Study Status
Completed
Study Phase
Phase 3
Countries
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

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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