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

Phase 4

Completed

• Conditions: Epilepsy, Partial Seizures

• Registration Number: NCT00275912
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-12
• Study Start: 2006-09-11
• Primary Completion: 2007-09-28
• Study Completion: 2007-09-28
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of patients requiring additional antiepileptic drugs
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

Trial Locations

Locations (5)

Russian State Medical University clinically based on Russian Pediatric Clinical Hospital; 🇷🇺 Moscow, Russian Federation

Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1; 🇷🇺 Ekaterinburg, Russian Federation

Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery; 🇷🇺 Moscow, Russian Federation

Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system; 🇷🇺 Moscow, Russian Federation

St. Petersburg State Pediatrics Medical Academy; 🇷🇺 St Petersburg, Russian Federation