Pediatric Epilepsy Study

Novartis

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: oxcarbazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00050947

CTRI476E2339

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 1 month to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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