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
94 participants
INTERVENTIONAL
2002-07-31
2004-02-29
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
* 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
* 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
1 Month
16 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
Madera, California, United States
Orange, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Ann Arbor, Michigan, United States
Duluth, Minnesota, United States
Saint Paul, Minnesota, United States
Chesterfields, Missouri, United States
St Louis, Missouri, United States
Buffalo, New York, United States
New York, New York, United States
Raleigh, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Spartenberg, South Carolina, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Brigadeiro Hospital
Sao Paulo - SP, , Brazil
Jena, , Germany
Kehl-Kork, , Germany
Kiel, , Germany
Novartis
Mexico City, , Mexico
Countries
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Other Identifiers
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CTRI476E2339
Identifier Type: -
Identifier Source: org_study_id