Overview

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