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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00195806 |
The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote ER is safe in the reduction of occurrence of migraine headaches in adolescents.
Condition | Intervention | Phase |
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Migraine |
Drug: divalproex sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Divalproex Sodium Extended-Release Tablets for Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study |
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of the following medication classes or any specific drug listed below:
Screening laboratory results indicate:
United States, Illinois | |
Global Medical Information - Abbott | |
North Chicago, Illinois, United States, 60064 |
Study Director: | Global Medical Information 800-633-9110 | Abbott |
Study ID Numbers: | M03-648 |
Study First Received: | September 14, 2005 |
Last Updated: | August 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00195806 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Migraine Depakote ER Divalproex sodium |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Diseases Central Nervous System Depressants Headache Disorders, Primary Brain Diseases |
Antimanic Agents Valproic Acid Headache Disorders Migraine Disorders Headache Anticonvulsants |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Diseases Central Nervous System Depressants Enzyme Inhibitors Headache Disorders, Primary |
Brain Diseases Antimanic Agents Valproic Acid Pharmacologic Actions Headache Disorders Migraine Disorders Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |