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.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00195754

First received: September 13, 2005

Last updated: July 30, 2007

Last verified: July 2007

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Migraine

Drug Information available for: Valproic acid Valproate sodium Divalproex 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 (Child)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00195754 History of Changes
Other Study ID Numbers:	M02-554
Study First Received:	September 13, 2005
Last Updated:	July 30, 2007

Keywords provided by Abbott:


Migraines Depakote ER divalproex sodium

Additional relevant MeSH terms:


Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Valproic Acid Anticonvulsants Enzyme Inhibitors	Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs

ClinicalTrials.gov processed this record on July 18, 2017

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