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Sponsored by: |
Abbott |
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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 |
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 |
Study Director: | Global Medical Information 800-633-9110 | Abbott |
Study ID Numbers: | M04-714 |
Study First Received: | February 1, 2005 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00102713 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Partial Seizures |
Neurotransmitter Agents Tranquilizing Agents Seizures Psychotropic Drugs Central Nervous System Diseases Central Nervous System Depressants Brain Diseases |
Antimanic Agents Valproic Acid Signs and Symptoms Epilepsy Neurologic Manifestations Anticonvulsants |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Seizures Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Diseases Central Nervous System Depressants Enzyme Inhibitors Brain Diseases |
Antimanic Agents Valproic Acid Pharmacologic Actions Signs and Symptoms Epilepsy Therapeutic Uses GABA Agents Neurologic Manifestations Central Nervous System Agents Anticonvulsants |