Efficacy, 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...
Brief Summary
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: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Oxcarbazepine
Outcome Measures for this Clinical Trial
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
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Chair Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00275912
