Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
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
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Epileptic activity at electroencephalography in restFlash 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 seizuresRate 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
Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system, Moscow, Russian Federation
Russian State Medical University clinically based on Russian Pediatric Clinical Hospital, Moscow, Russian Federation
Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery, Moscow, Russian Federation
St. Petersburg State Pediatrics Medical Academy, St Petersburg, Russian Federation
Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1, Ekaterinburg, Russian Federation
Additional Information
Starting date: December 2005
Ending date: September 2007
Last updated: December 4, 2007
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