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

Epilepsy, Partial Seizures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00275912
• Other study ID #: CTRI476BRU02
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2006
• Last updated: February 20, 2017
• Start date: September 11, 2006
• Est. completion date: September 28, 2007

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 28, 2007
• Est. primary completion date: September 28, 2007
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy, Partial Seizures
• Seizures

Intervention

Drug:
• Oxcarbazepine

Locations

Country	Name	City	State
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	Russian State Medical University clinically based on Russian Pediatric Clinical Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epileptic activity at electroencephalography in rest
Primary	Flash light and hyperventilation test with electroencephalography
Primary	Frequency of epileptic episodes according to patient's diary
Primary	Electrocardiogram analysis for rhythm and conduction
Primary	Blood test for sodium, hepatic enzymes and blood cells
Secondary	Tolerability and safety of 24 week's treatment with oxcarbazepine monotherapy in children with partial seizures
Secondary	Rate of patients with total and partial control of epilepsy
Secondary	Rate of patients requiring additional antiepileptic drugs

External Links

•   Results for CTRI476BRU02 from the Novartis Clinical Trials Website