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

Eisai Clinical Trials

Protocol # E2080-J081-305

Study Overview

Study Compound: E2080

Drug Name: rufinamide

Registry #: NCT01151540, 2016-004953-34

Trial Period: Nov 2010 - Aug 2013

Indication: Lennox-Gastaut Syndrome

Primary Endpoint:
1. 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]

Population
Males and females 4 Years to 30 Years (Child, Adult)
Study Status
Completed
Study Phase
Phase 3
Countries
Japan

Clinical Trial Documents

Clinical Study Report Synopsis

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Plain Language Protocol Synopsis (PLPS)

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Plain Language Summary of Results (PLS)

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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.

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