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Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)

NCT00566254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2013-05-13

Study results available
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Summary

The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.

Conditions

  • Epilepsy; Paediatric Partial Onset Seizures

Interventions

DRUG

Zonisamide

8mg/kg per day for approximately 24 weeks.

DRUG

Placebo

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Joanna Segieth, PhD · Eisai Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Belgium
  • Estonia
  • France
  • Hungary
  • Italy
  • Latvia
  • Poland
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00566254 on ClinicalTrials.gov