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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Brief Summary

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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

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Conditions

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Migraines

Keywords

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Migraines Depakote ER divalproex sodium

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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divalproex sodium

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Global Medical Information 800-633-9110

Role: STUDY_DIRECTOR

Abbott

Locations

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Global Medical Information - Abbott

North Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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M02-554

Identifier Type: -

Identifier Source: org_study_id