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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00195806
First received: September 14, 2005
Last updated: August 30, 2007
Last verified: August 2007
  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
Migraine
Drug: divalproex sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Divalproex Sodium Extended-Release Tablets for Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Number of migraine headache days

Secondary Outcome Measures:
  • Adverse events
  • Laboratory data
  • Vital signs
  • Study drug exposure
  • Behavioral/cognitive assessments

Estimated Enrollment: 315
Study Start Date: February 2005
  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;
  • 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.
  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: NCT00195806

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

ClinicalTrials.gov Identifier: NCT00195806     History of Changes
Other Study ID Numbers: M03-648
Study First Received: September 14, 2005
Last Updated: August 30, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Migraine
Depakote ER
Divalproex sodium

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014