Eisai Clinical Trials

A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)

E2090-E044-312

Study Overview

E2090
zonisamide
NCT00566254, EU CTR 2006-002515-27
Dec 2008 - Mar 2011
Paediatric Partial Onset Seizures
Percentage of Participants With a Decrease From Baseline in 28-day Seizure Frequency of =50%(Responder) in the Maintenance Period(LOCF) [ Time Frame: Baseline (Week -8 to Week 0), and Week 8 to Week 20 ]

  • Males and females (age 6 years to 17 years)

  • Completed

  • Phase 3

  • Belgium, Estonia, France, Hungary, Italy, Latvia, Poland, Spain, Ukraine See more

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Guerrini R et al. A randomized phase III trial of adjunctive zonisamide in pediatric patients with partial epilepsy. Epilepsia 2013; 54.8: 1473-1480. DOI: http://dx.doi.org/10.1111/epi.12233

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