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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy, Partial Seizures

Intervention: Oxcarbazepine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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 outcome:

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

Eligibility

Minimum age: 6 Months. Maximum age: 17 Years. Gender(s): Both.

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.

Locations and Contacts

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, Russian Federation

Additional Information

Starting date: December 2005
Last updated: May 7, 2012

Page last updated: August 23, 2015

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