A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Adjunctive Therapy in Pediatric Patients With Inadequately-controlled Partial Seizures.

Novartis Pharmaceuticals2 sites in 2 countries132 target enrollmentJune 2002

ConditionsEpilepsy Epilepsies, Partial

Drugsoxcarbazepine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Epilepsy
Sponsor: Novartis Pharmaceuticals
Enrollment: 132
Locations: 2
Primary Endpoint: change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2002

End Date

June 2004

Last Updated

14 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

% 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).