A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients

Eisai Clinical Trials

Protocol # E2080-J081-304

Study Overview

Study Compound: E2080

Drug Name: rufinamide

Registry #: NCT01146951, 2016-004952-30

Trial Period: Jun 2010 - Aug 2011

Indication: Lennox-Gastaut Syndrome

Primary Endpoint:
1. Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days) [Time Frame: Baseline (28 day observational period) and End of Treatment (28 day treatment period)]

Population
Males and females 4 Years to 30 Years (Child, 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

Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.

Panebianco M, Prabhakar H, Marson AG. Rufinamide add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Nov 8;11(11):CD011772. doi: 10.1002/14651858.CD011772.pub3.

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