A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488. - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

July 30, 2007

Start Date ^†

July 2004

Current Primary Outcome Measures ^†

Safety outcome measure [ Time Frame: 12 months ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00195754 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Migraine headache rate [ Time Frame: 12 months ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488.

Official Title ^†

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Migraines

Intervention ^†

Drug: divalproex sodium

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

114

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

12 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00195754

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Abbott

Collaborators ^††

Investigators ^†

Study Director:

Global Medical Information 800-633-9110

Abbott

Information Provided By

Abbott

Verification Date

July 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.