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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxcarbazepine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Scientific Research Institute of Pediatrics and Pediatric Surgery | Moscow | Russia | ||||
| Russian State Medical University clinically based on Russian Pediatric Clinical Hospital |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Rate of patients requiring additional antiepileptic drugs |
| Moscow |
| Russia |
| Scientific-practical centre of children treatment suffering from craniofacial malformation and congenital pathology of nervous system | Moscow | Russia |
| St. Petersburg State Pediatrics Medical Academy | Saint Petersburg | Russia |
| Regional Pediatric Clinical Hospital №1 EkaterinburgRegional Pediatric Clinical Hospital №1 | Yekaterinburg | Russia |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |