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

Study Type: Interventional

Study Design: Treatment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: oxcarbazepine

Primary Measures

• Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.

Secondary Measures

• Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00050947

Study ID Number: CTRI476E2339

ClinicalTrials.gov Identifier: NCT00050947

Health Authority: United States: Food and Drug Administration