Eisai Clinical Trials

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

E2080-J081-304

Study Overview

E2080
rufinamide
NCT01146951, EU CTR 2016-004952-30
Jun 2010 - Aug 2011
Lennox-Gastaut Syndrome
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)]

  • Males and females (age 4 years to 30 years)

  • Completed

  • Phase 3

  • Japan

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Ohtsuka Y et al. Rufinamide as an adjunctive therapy for Lennox-Gastaut syndrome: A randomized double-blind placebo-controlled trial in Japan. Epilepsy Research 2014; 108.9: 1627-1636. DOI: http://dx.doi.org/10.1016/j.eplepsyres.2014.08.019

Panebianco M et al. Rufinamide add-on therapy for drug-resistant epilepsy. The Cochrane database of systematic reviews 2020; 11 : CD011772. DOI: http://dx.doi.org/10.1002/14651858.CD011772.pub3

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