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Pediatric Epilepsy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00050947
Recruitment Status : Completed
First Posted : January 1, 2003
Last Update Posted : November 23, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: oxcarbazepine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2002
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3.

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050947


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35233
Mobile, Alabama, United States, 36693
United States, California
Madera, California, United States, 93638
Orange, California, United States, 92868
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Miami, Florida, United States, 33155
Tampa, Florida, United States, 33607
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Duluth, Minnesota, United States, 55805
St. Paul, Minnesota, United States, 55102
United States, Missouri
Chesterfields, Missouri, United States, 63017
St. Louis, Missouri, United States, 63110
United States, New York
Buffalo, New York, United States, 14222
New York, New York, United States, 10016
United States, North Carolina
Raleigh, North Carolina, United States, 27607
United States, Ohio
Akron, Ohio, United States, 44308
Cincinnati, Ohio, United States, 45229
Cleveland, Ohio, United States, 44106
United States, Oregon
Portland, Oregon, United States, 97201
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Spartenberg, South Carolina, United States, 29303
United States, Texas
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77030
Brazil
Brigadeiro Hospital
Sao Paulo - SP, Brazil, 01401-901
Germany
Jena, Germany, 07740
Kehl-Kork, Germany, 77694
Kiel, Germany, 24105
Mexico
Novartis
Mexico City, Mexico
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00050947    
Other Study ID Numbers: CTRI476E2339
First Posted: January 1, 2003    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
partial seizures
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxcarbazepine
Anticonvulsants
 Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers