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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxcarbazepine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to meeting one of the exit criteria starting from the first dose of oxcarbazepine on Day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients meeting one of the exit criteria and the electrographic partial seizure frequency/24 hours during the treatment phase |
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INCLUSION CRITERIA: To enter this study, patients must:
EXCLUSION CRITERIA: To enter this study, a patient must not have or be:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
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| Mobile |
| Alabama |
| 36693 |
| United States |
| Madera | California | 93638 | United States |
| Orange | California | 92868 | United States |
| Denver | Colorado | 80218 | United States |
| Miami | Florida | 33155 | United States |
| Tampa | Florida | 33607 | United States |
| Atlanta | Georgia | 30342 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Duluth | Minnesota | 55805 | United States |
| Saint Paul | Minnesota | 55102 | United States |
| Chesterfields | Missouri | 63017 | United States |
| St Louis | Missouri | 63110 | United States |
| Buffalo | New York | 14222 | United States |
| New York | New York | 10016 | United States |
| Raleigh | North Carolina | 27607 | United States |
| Akron | Ohio | 44308 | United States |
| Cincinnati | Ohio | 45229 | United States |
| Cleveland | Ohio | 44106 | United States |
| Portland | Oregon | 97201 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Spartenberg | South Carolina | 29303 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77030 | United States |
| Brigadeiro Hospital | Sao Paulo - SP | 01401-901 | Brazil |
| Jena | 07740 | Germany |
| Kehl-Kork | 77694 | Germany |
| Kiel | 24105 | Germany |
| Novartis | Mexico City | Mexico |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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