Pediatric Epilepsy Study

Condition(s) targeted: Epilepsy

Intervention: oxcarbazepine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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 design: Treatment, Safety/Efficacy Study

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

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

Minimum age: 1 Month. Maximum age: 16 Years. Gender(s): Both.

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

Brigadeiro Hospital, Sao Paulo - SP 01401-901, Brazil

Jena 07740, Germany

Kehl-Kork 77694, Germany

Kiel 24105, Germany

Novartis, Mexico City, Mexico

Birmingham, Alabama 35233, United States

Mobile, Alabama 36693, United States

Madera, California 93638, United States

Orange, California 92868, United States

Denver, Colorado 80218, United States

Miami, Florida 33155, United States

Tampa, Florida 33607, United States

Atlanta, Georgia 30342, United States

Ann Arbor, Michigan 48109, United States

Duluth, Minnesota 55805, United States

St. Paul, Minnesota 55102, United States

St. Louis, Missouri 63110, United States

Chesterfields, Missouri 63017, United States

New York, New York 10016, United States

Buffalo, New York 14222, United States

Raleigh, North Carolina 27607, United States

Cincinnati, Ohio 45229, United States

Cleveland, Ohio 44106, United States

Akron, Ohio 44308, United States

Portland, Oregon 97201, United States

Pittsburgh, Pennsylvania 15213, United States

Philadelphia, Pennsylvania 19104, United States

Spartenberg, South Carolina 29303, United States

Fort Worth, Texas 76104, United States

Houston, Texas 77030, United States

Houston, Texas 77030, United States

Starting date: July 2002
Ending date: February 2004
Last updated: November 29, 2007