Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00195806
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 3, 2007
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Migraine Drug: divalproex sodium Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 315 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Divalproex Sodium Extended-Release Tablets for Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study
Study Start Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Primary Outcome Measures :
  1. Number of migraine headache days

Secondary Outcome Measures :
  1. Adverse events
  2. Laboratory data
  3. Vital signs
  4. Study drug exposure
  5. Behavioral/cognitive assessments

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
  • Subject is male, or a non-pregnant, non-lactating female;
  • Subject is between 12 and 17 years of age, inclusive, at the Screening Visit;
  • Subject weighs at least 77 lbs. (i.e., 35 kg);
  • Subject currently has diagnosis of migraine headaches consistent with International Headache Society (IHS) criteria;
  • Subject is judged to be in generally good health based on the results of a medical history, physical examination, 12-lead electrocardiogram (ECG), and laboratory profile; and
  • In the investigator's opinion, the subject will benefit from Depakote ER for migraine prophylaxis.

Exclusion Criteria:

  • History of allergic reaction or significant sensitivity to valproate or similar drugs;
  • History of noncompliance with medication or medical instructions;
  • Recent (previous 6 months) history of drug and/or alcohol abuse or has a positive urine drug screen, at the Screening Visit, for drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, opiates, and phencyclidine [PCP]);
  • Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives) as judged by the investigator.
  • Use of the following medication classes or any specific drug listed below:

    • anti-depressants, other antiepileptic drugs (AEDs)
    • aspirin and/or aspirin-containing products
    • chronic use of systemic corticosteroids, clonazepam,diazepam, erythromycin, ethosuximide, pemoline, phenobarbital,rifampin,tolbutamide, zidovudine
    • anticoagulant drug therapy;
  • Any serious medical or psychiatric disorder(s), including epilepsy and obesity, that may confound the interpretation of the results from this study;
  • Central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease;
  • History of encephalopathy, hepatitis, pancreatitis, or urea-cycle disorder or any underlying condition/disease, which might interfere with study drug absorption or completion of study drug therapy evaluation throughout the duration of the trial;
  • Screening laboratory results indicate the presence of Hepatitis B surface antigen (HBsAg), or Hepatitis C antibody or known history of any positive test result for HIV;
  • Screening laboratory results indicate:

    1. Platelet count =/< 100,000/uL
    2. ALT or AST =/> 2 times Upper Limit of Normal (ULN);
  • Receipt of an investigational drug within 30 days prior to study drug administration or scheduled to receive any other investigational drug anytime during the study;
  • Participation in a prior Depakote ER migraine study (M02-488 or M02-554); or if for any reason, subject is considered by the investigator to be an unsuitable candidate to receive Depakote or to participate in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00195806

United States, Illinois
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064
Sponsors and Collaborators
Study Director: Global Medical Information 800-633-9110 Abbott Identifier: NCT00195806     History of Changes
Other Study ID Numbers: M03-648
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 3, 2007
Last Verified: August 2007

Keywords provided by Abbott:
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
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