Pediatric Epilepsy Study

Phase 3

Completed

• Conditions: Epilepsy

• Registration Number: NCT00050947
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2002-12-30
• Study First Submitted QC: 2002-12-31
• Study First Posted: 2003-01-01
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-22
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase

Trial Locations

Locations (2)

Novartis; 🇲🇽 Mexico City, Mexico

Brigadeiro Hospital; 🇧🇷 Sao Paulo - SP, Brazil