Pediatric Epilepsy Study

Official Title: “A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Adjunctive Therapy in Pediatric Patients With Inadequately-controlled Partial Seizures.”

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.

Intervention(s) in this Clinical Trial

• Drug: oxcarbazepine

Primary Measures

• change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)

Secondary Measures

• % change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 1 Month

Maximum Age for this Clinical Trial: 3 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00050934

Study ID Number: CTRI476E 2340

ClinicalTrials.gov Identifier: NCT00050934

Health Authority: United States: Food and Drug Administration