Eisai Clinical Trials

A Multicenter, Randomized, Controlled, Open-label Study to Evaluate the Cognitive Development Effects and Safety, and Pharmacokinetics of Adjunctive Rufinamide Treatment in Pediatric Subjects 1 to Less Than 4 Years of Age With Inadequately Controlled Lennox-Gastaut Syndrome

E2080-G000-303

Study Overview

E2080
rufinamide
NCT01405053, EU CTR 2010-023505-36
Jun 2011 - Oct 2015
Lennox-Gastaut Syndrome
Child Behaviour Checklist (CBCL) Total Problems Score at the end of the 2 year treatment period.

  • Males and females (age 1 to 3 years)

  • Completed

  • Phase 3

  • Canada, France, Greece, Italy, Poland, United States See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Arzimanoglou A, et al. Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study. European Journal of Paediatric Neurology 2016 May 01;20(3):393-402. DOI: 10.1016/j.ejpn.2015.12.015

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