Pediatric Epilepsy Study

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

This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Epilepsies, Partial
• Intervention / Treatment: Drug: oxcarbazepine

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo - SP, Brazil, 01401-901
    • Brigadeiro Hospital
• Germany
  • 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
    • Los Angeles, California, United States, 90027
    • Los Angeles, California, United States, 90095
    • Madera, California, United States, 93638
    • Orange, California, United States, 92868
  • Delaware
    • Wilmington, Delaware, United States, 19806
  • Florida
    • Miami, Florida, United States, 33155
    • Tampa, Florida, United States, 33607
  • Georgia
    • Atlanta, Georgia, United States, 30342
  • Idaho
    • Boise, Idaho, United States, 83712
  • 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
  • New York
    • Buffalo, New York, United States, 14222
    • New York, New York, United States, 10016
    • New York, New York, United States, 10032
  • 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
  • Texas
    • Fort Worth, Texas, United States, 76104
    • Houston, Texas, United States, 77030
  • Virginia
    • Norfolk, Virginia, United States, 23507

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 months (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
• Be willing to be hospitalized
• Weigh a minimum of 6.6 pounds
• Be taking a stable dose of one to two concomitant anti-epileptic medications
• 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
• Frequent use of additional anti-epileptic medications to treat increases in seizures (for example: rectal diazepam)
• Taking felbamate within 6 months
• 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
• 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
change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline)

Secondary Outcome Measures

Outcome Measure
% change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours).

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): June 1, 2004
• Study Completion (Actual): June 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; Epilepsies, Partial; 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: CTRI476E 2340