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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.

Primary Purpose

Migraines

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
divalproex sodium
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraines focused on measuring Migraines, Depakote ER, divalproex sodium

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Global Medical Information - Abbott

Outcomes

Primary Outcome Measures

Safety outcome measure

Secondary Outcome Measures

Migraine headache rate

Full Information

First Posted
September 13, 2005
Last Updated
July 30, 2007
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00195754
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraines
Keywords
Migraines, Depakote ER, divalproex sodium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
divalproex sodium
Primary Outcome Measure Information:
Title
Safety outcome measure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Migraine headache rate
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information 800-633-9110
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information - Abbott
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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.

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