Epilepsy, Partial Seizures
Conditions
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.
Interventions
DRUGOxcarbazepine
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
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/
Design outcomes
Primary
| Measure | 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 | — |
Secondary
| Measure | 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 | — |
| Rate of patients requiring additional antiepileptic drugs | — |
Countries
Russia
Outcome results
None listed