Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
132 participants
INTERVENTIONAL
2002-06-30
2004-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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oxcarbazepine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Month
3 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Los Angeles, California, United States
Los Angeles, California, United States
Madera, California, United States
Orange, California, United States
Wilmington, Delaware, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Ann Arbor, Michigan, United States
Duluth, Minnesota, United States
Saint Paul, Minnesota, United States
Chesterfields, Missouri, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Brigadeiro Hospital
Sao Paulo - SP, , Brazil
Kehl-Kork, , Germany
Kiel, , Germany
Novartis
Mexico City, , Mexico
Countries
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Other Identifiers
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CTRI476E 2340
Identifier Type: -
Identifier Source: org_study_id