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.

This study has been completed.

First Received: September 13, 2005 Last Updated: July 30, 2007 History of Changes

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00195754

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.

Condition	Intervention	Phase
Migraines	Drug: divalproex sodium	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Divalproex sodium Valproic acid Valproate Sodium

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Safety outcome measure [ Time Frame: 12 months ]

Secondary Outcome Measures:

Migraine headache rate [ Time Frame: 12 months ]

Enrollment:	114
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195754

Locations

United States, Illinois
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Global Medical Information 800-633-9110

Abbott

More Information

No publications provided

Study ID Numbers:	M02-554
Study First Received:	September 13, 2005
Last Updated:	July 30, 2007
ClinicalTrials.gov Identifier:	NCT00195754 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Migraines
Depakote ER
divalproex sodium

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Psychotropic Drugs
Central Nervous System Diseases
Central Nervous System Depressants
Headache Disorders, Primary
Brain Diseases

Antimanic Agents
Valproic Acid
Headache Disorders
Migraine Disorders
Headache
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Diseases
Central Nervous System Depressants
Enzyme Inhibitors
Headache Disorders, Primary

Brain Diseases
Antimanic Agents
Valproic Acid
Pharmacologic Actions
Headache Disorders
Migraine Disorders
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on August 30, 2009