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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00195741 |
The purpose of this study is to determine whether Depakote ER is safe and effective 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, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Phase III, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Center Study Designed to Evaluate the Safety and Efficacy of Prophylactic Depakote ER in the Treatment of Adolescent Migraine |
Estimated Enrollment: | 300 |
Study Start Date: | May 2003 |
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Experimental Phase
Experimental Phase and subsequent randomization and study drug assignment:
Exclusion Criteria Baseline Phase
Use of the following medication classes or any specific drug listed below:
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: | M02-488 |
Study First Received: | September 13, 2005 |
Last Updated: | February 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00195741 |
Health Authority: | United States: Food and Drug Administration |
Migraine Depakote ER |
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 |