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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00050934 |
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.
Condition | Intervention | Phase |
---|---|---|
Epilepsy Epilepsies, Partial |
Drug: oxcarbazepine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Estimated Enrollment: | 128 |
Study Start Date: | October 2002 |
Study Completion Date: | June 2004 |
Ages Eligible for Study: | 1 Month to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA: To enter this study, patients must:
EXCLUSION CRITERIA: To enter this study, a patient must not have or be:
Study ID Numbers: | CTRI476E 2340 |
Study First Received: | December 30, 2002 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00050934 |
Health Authority: | United States: Food and Drug Administration |
partial seizures |
Epilepsies, Partial Oxcarbazepine Epilepsy |
Seizures Central Nervous System Diseases Brain Diseases |
Therapeutic Uses Nervous System Diseases Central Nervous System Agents Pharmacologic Actions Anticonvulsants |