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| Sponsored by: |
Abbott |
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00067431 |
Purpose
The purpose of this study is to compare the safety and efficacy of two concentration ranges of valproate using Depakote Sprinkle Capsules as adjunctive therapy in the treatment of partial seizures, with or without secondary generalization, in children 3-10 years.
| Condition | Intervention | Phase |
|
Partial Seizure Disorder |
Drug: Divalproex Sodium (Depakote® Sprinkle Capsules) |
Phase III |
| Genetics Home Reference related topics: | autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy |
| MedlinePlus related topics: | Epilepsy Seizures |
| Drug Information available for: | Divalproex sodium Valproate Sodium Valproic acid |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study of the Safety and Efficacy of Depakote Sprinkle Capsules in the Treatment of Partial Seizures in Children |
Eligibility
| Ages Eligible for Study: | 3 Years to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Subject has diagnosis of partial seizures with/without secondary generalization, supported by:
EXCLUSION CRITERIA:
Contacts and Locations| United States, Florida | |||||
| Pediatric Epilepsy & Neurology Specialist | |||||
| Tampa, Florida, United States, 33607 | |||||
| United States, Ohio | |||||
| PCTI / Children's Hospital | |||||
| Columbus, Ohio, United States, 43205 | |||||
| University Hospital of Cleveland | |||||
| Cleveland, Ohio, United States | |||||
| Rainbow Babies Children's Hospital | |||||
| Cleveland, Ohio, United States, 44106 | |||||
| United States, Pennsylvania | |||||
| Primary Physician's Research | |||||
| Pittsburgh, Pennsylvania, United States | |||||
| United States, Texas | |||||
| Texas Association of Pediatric Neurology, PA | |||||
| San Antonio, Texas, United States, 78258 | |||||
| United States, Virginia | |||||
| Virginia Commonwealth University | |||||
| Richmond, Virginia, United States, 23298-0211 | |||||
| Abbott |
| Study Director: | Laura Redden, M.D., Ph.D. | Medical Director |
More Information
| Study ID Numbers: | M02-552 |
| First Received: | August 19, 2003 |
| Last Updated: | August 2, 2006 |
| ClinicalTrials.gov Identifier: | NCT00067431 |
| Health Authority: | United States: Food and Drug Administration |
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