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, 2010-023505-36
Jun 2011 - Nov 2015
Lennox-Gastaut Syndrome

1. Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period [Time Frame: End of Treatment Period (up to approximately Week 106)]

2. Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period [Time Frame: Baseline and End of Treatment Period (up to approximately Week 106)]

  • Males and females 1 Year to 3 Years (Child)

  • 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

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.

Auvin S, Williams B, McMurray R, Kumar D, Perdomo C, Malhotra M. Novel seizure outcomes in patients with Lennox-Gastaut syndrome: Post hoc analysis of seizure-free days in rufinamide Study 303. Epilepsia Open. 2019 Mar 13;4(2):275-280. doi: 10.1002/epi4.12314. eCollection 2019 Jun.

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