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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 |
---|---|---|
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 |
Health Authority: | United States: Food and Drug Administration |
Migraine Depakote ER Divalproex sodium |
Migraine Disorders Headache Central Nervous System Diseases Headache Disorders, Primary |
Brain Diseases Valproic Acid Headache Disorders |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Enzyme Inhibitors Antimanic Agents Pharmacologic Actions Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |