Expired Study
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Atlanta, Georgia 30342


This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.


INCLUSION CRITERIA: To enter this study, patients must: - Have a diagnosis of partial seizures - Be willing to be hospitalized - Weigh a minimum of 6.6 pounds - Be taking a stable dose of one to two concomitant anti-epileptic medications - 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 - Frequent use of additional anti-epileptic medications to treat increases in seizures (for example: rectal diazepam) - Taking felbamate within 6 months - 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 - Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds - Used experimental medication within 30 days of entering this study



Primary Contact:

Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals

Backup Contact:


Location Contact:

Atlanta, Georgia 30342
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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