Pediatric Epilepsy Study

A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Monotherapy in Pediatric Patients With Inadequately-controlled Partial Seizures.

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 Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: oxcarbazepine

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo - SP, Brazil, 01401-901
    • Brigadeiro Hospital
• Germany
  • Jena, Germany, 07740
  • Kehl-Kork, Germany, 77694
  • Kiel, Germany, 24105
• Mexico
  • Mexico City, Mexico
    • Novartis
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
    • Mobile, Alabama, United States, 36693
  • California
    • Madera, California, United States, 93638
    • Orange, California, United States, 92868
  • Colorado
    • Denver, Colorado, United States, 80218
  • Florida
    • Miami, Florida, United States, 33155
    • Tampa, Florida, United States, 33607
  • Georgia
    • Atlanta, Georgia, United States, 30342
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
  • Minnesota
    • Duluth, Minnesota, United States, 55805
    • St. Paul, Minnesota, United States, 55102
  • Missouri
    • Chesterfields, Missouri, United States, 63017
    • St. Louis, Missouri, United States, 63110
  • New York
    • Buffalo, New York, United States, 14222
    • New York, New York, United States, 10016
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
  • Ohio
    • Akron, Ohio, United States, 44308
    • Cincinnati, Ohio, United States, 45229
    • Cleveland, Ohio, United States, 44106
  • Oregon
    • Portland, Oregon, United States, 97201
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
    • Pittsburgh, Pennsylvania, United States, 15213
  • South Carolina
    • Spartenberg, South Carolina, United States, 29303
  • Texas
    • Fort Worth, Texas, United States, 76104
    • Houston, Texas, United States, 77030

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.

Secondary Outcome Measures

Outcome Measure
Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): February 1, 2004
• Study Completion (Actual): February 1, 2004

Study Registration Dates

• First Submitted: December 30, 2002
• First Submitted That Met QC Criteria: December 31, 2002
• First Posted (Estimate): January 1, 2003

Study Record Updates

• Last Update Posted (Estimate): November 23, 2011
• Last Update Submitted That Met QC Criteria: November 22, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: partial seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Oxcarbazepine
• Other Study ID Numbers: CTRI476E2339