Pediatric Epilepsy Study

Phase 3

Completed

• Conditions: Epilepsy; Epilepsies, Partial

• Registration Number: NCT00050934
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-12-30
• Study First Submitted QC: 2002-12-31
• Study First Posted: 2003-01-01
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-22
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)

Secondary Outcome Measures

Name	Time	Method
% change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).

Trial Locations

Locations (2)

Novartis; 🇲🇽 Mexico City, Mexico

Brigadeiro Hospital; 🇧🇷 Sao Paulo - SP, Brazil