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A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)

NCT01136954 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2016-01-25

Study results available
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Summary

The purpose of this study is to assess the long-term safety and efficacy of zonisamide used as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic drugs (AEDs).

Conditions

  • Partial Seizures

Interventions

DRUG

Zonisamide

Transition Period from Study E2090-E044-312: Placebo Open-Label Period: 1 to 8 mg/kg orally per day for approximately 59 weeks.

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Principal Investigators

  • Rob van Maanen, M.D., MFPM · Eisai Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2012-01-31
Completion
2012-03-31

Countries

  • Italy

Study Locations

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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 NCT01136954 on ClinicalTrials.gov