Official Title: “The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: divalproex sodium

Primary Measures

• Safety outcome measure
  • Time Frame: 12 months
    

Secondary Measures

• Migraine headache rate
  • Time Frame: 12 months
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Global Medical Information 800-633-9110 Study Director Abbott  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00195754

Study ID Number: M02-554

ClinicalTrials.gov Identifier: NCT00195754

Health Authority: United States: Food and Drug Administration