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.
