Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

• Status: Completed
• Trial end date: 2007-09-28
• Target enrollment: 0
• Participant gender: All

Summary

This study is aimed to collect additional data regarding the efficacy in reducing the frequency of partial seizures, as well as the safety and tolerability, of oxcarbazepine monotherapy in children.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis
• Treatments: Carbamazepine; Oxcarbazepine

Criteria

Inclusion Criteria:

• males and females, 6 months - 17 years of age;

• diagnosis of epilepsy, partial seizures;

• ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous antiepileptic therapy

Exclusion Criteria:

• progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;

• non-epileptic seizures;

• drug or alcohol dependence during a year prior to screening;

Other protocol-defined inclusion/exclusion criteria may apply.