Eisai Clinical Trials

An Open-label Extension Study Following a Double-blind, Randomized, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Pediatric Partial Onset Seizures (CATZ Extension Study)

E2090-E044-313

Study Overview

E2090
zonisamide
NCT01136954, EU CTR 2007-000198-53
Jul 2008 - Mar 2012
Paediatric Partial Onset Seizures
Treatment Emergent Non-Serious Adverse Events With Greater Than 5% Frequency [ Time Frame: Week 1 through Week 59 ]

  • Males and females (age 6 years to 18 years)

  • Completed

  • Phase 3

  • Italy

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Guerrini R et al. Adjunctive zonisamide therapy in the long-term treatment of children with partial epilepsy: Results of an open-label extension study of a phase III, randomized, double-blind, placebo-controlled trial. Epilepsia 2014; 55.4: 568-578. DOI: http://dx.doi.org/10.1111/epi.12548

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