Official Title: “A 24-Week Prospective Open-Label Multicenter Study to Evaluate the Effect on Seizure Frequency, Safety and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: Oxcarbazepine

Primary Measures

• Epileptic activity at electroencephalography in rest
• Flash light and hyperventilation test with electroencephalography
• Frequency of epileptic episodes according to patient's diary
• Electrocardiogram analysis for rhythm and conduction
• Blood test for sodium, hepatic enzymes and blood cells

Secondary Measures

• Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in children with partial seizures
• Rate of patients with total and partial control of epilepsy
• Rate of patients requiring additional antiepileptic drugs

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 17 Years

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Chair Novartis  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00275912

Study ID Number: CTRI476BRU02

ClinicalTrials.gov Identifier: NCT00275912

Health Authority: Russia: Ministry of Health and Social Development of the Russian Federation