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Sponsored by: |
Abbott |
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00102713 |
The purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.
Condition | Intervention | Phase |
Partial Seizures |
Drug: Divalproex Sodium (Depakote Sprinkle Capsules) |
Phase III |
Genetics Home Reference related topics: | pyridoxal 5'-phosphate-dependent epilepsy |
MedlinePlus related topics: | Seizures |
ChemIDplus related topics: | Divalproex sodium Valproate Sodium Valproic acid |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open Label Study for Treatment of Partial Seizures in Children |
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:
1 of following 3:
Exclusion Criteria:
United States, Alabama | |||||
Neurology Clinic, P.C. | |||||
Northport, Alabama, United States | |||||
United States, Arizona | |||||
St. Joseph's Hospital and Medical Center | |||||
Phoenix, Arizona, United States, 85013 | |||||
United States, Florida | |||||
Pediatric Epilepsy and Neurology Specialists | |||||
Tampa, Florida, United States | |||||
United States, Georgia | |||||
Child Neurology Associates, P.C. | |||||
Atlanta, Georgia, United States | |||||
United States, Ohio | |||||
Akron Children’s Hospital | |||||
Akron, Ohio, United States, 44308 1062 | |||||
University Hospitals of Cleveland | |||||
Cleveland, Ohio, United States, 44106 | |||||
United States, Texas | |||||
Texas Association of Pediatric Neurology, P.A. | |||||
San Antonio, Texas, United States | |||||
United States, Virginia | |||||
Monarch Medical Research | |||||
Norfolk, Virginia, United States, 23510 | |||||
Virginia Commonwealth University Medical Center | |||||
Richmond, Virginia, United States, 23298-0211 | |||||
United States, Wisconsin | |||||
Richard V. Colan, M.D., S.C. | |||||
Milwaukee, Wisconsin, United States, 53226 |
Abbott |
Study Director: | Global Medical Information 800-633-9110 | Abbott |
Study ID Numbers: | M04-714 |
First Received: | February 1, 2005 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00102713 |
Health Authority: | United States: Food and Drug Administration |
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