Expired Study
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North Chicago, Illinois 60064


Purpose:

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.


Criteria:

Inclusion Criteria: - Subject and subject's legal representative have voluntarily signed and dated an IRB-approved informed assent form and an IRB-approved informed consent form, respectively, before any study-specific procedures or tests are performed; - The subject was randomized into Study M02-488 and either completed the study or prematurely discontinued due to ineffectiveness; and - The subject is male or non-pregnant, non-lactating female Exclusion Criteria - Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives). - Experienced a serious adverse event in Study M02-488 which the investigator considered "possibly" or "probably related" to study drug; or - In the investigator's opinion, long-term treatment with Depakote ER for migraine prophylaxis is contraindicated. - For any reason, subject is considered by the investigator to be an unsuitable candidate to receive divalproex sodium or to participate in this study.


NCT ID:

NCT00195754


Primary Contact:

Study Director
Global Medical Information 800-633-9110
Abbott


Backup Contact:

N/A


Location Contact:

North Chicago, Illinois 60064
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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