Eisai Clinical Trials

A Long Term Extension Study of E2080 in Lennox-Gastaut Patients

E2080-J081-305

Study Overview

E2080
rufinamide
NCT01151540, EU CTR 2016-004953-34
Nov 2010 - Aug 2013
Lennox-Gastaut Syndrome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Rufinamide [ Time Frame: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 years 10 months ]

  • 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. Long-term safety and seizure outcome in Japanese patients with Lennox-Gastaut syndrome receiving adjunctive rufinamide therapy: An open-label study following a randomized clinical trial. Epilepsy Research 2016; 121: 1-7. DOI: http://dx.doi.org/10.1016/j.eplepsyres.2016.01.002

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