Pediatric Epilepsy Study

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Carbamazepine; Oxcarbazepine

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