Pediatric Epilepsy Study
Epilepsy
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring partial seizures
Eligibility Criteria
INCLUSION CRITERIA: To enter this study, patients must: Have a diagnosis of partial seizures Have 2-30 seizures per week while on a stable dose of one anti-epileptic drug or be a patient recently diagnosed with partial seizures and currently receiving no seizure medication Be willing to be hospitalized for up to 5 days Weigh a minimum of 6.6 lbs Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease Have normal laboratory results EXCLUSION CRITERIA: To enter this study, a patient must not have or be: Seizures caused by metabolic disturbance, toxic exposure, or active infection A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures) A history of status epilepticus within 30 days Seizures not related to epilepsy This study has some AED restrictions Serum sodium levels <135 mEq/L Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy A history of chronic infection (e.g., hepatitis or HIV) Significant electrocardiogram (ECG) abnormalities A nursing mother taking anti-convulsant drugs A history of substance abuse (including alcohol) Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds Used experimental medication within 30 days of entering this study
Sites / Locations
- Brigadeiro Hospital
- Novartis