Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine
- Conditions
- Migraine
- Registration Number
- NCT00195806
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 315
- 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.
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History of allergic reaction or significant sensitivity to valproate or similar drugs;
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History of noncompliance with medication or medical instructions;
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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]);
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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.
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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;
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Any serious medical or psychiatric disorder(s), including epilepsy and obesity, that may confound the interpretation of the results from this study;
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Central nervous system (CNS) neoplasm, CNS infection, demyelinating disease, degenerative neurological disease, or any progressive CNS disease;
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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;
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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;
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Screening laboratory results indicate:
- Platelet count =/< 100,000/uL
- ALT or AST =/> 2 times Upper Limit of Normal (ULN);
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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;
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of migraine headache days
- Secondary Outcome Measures
Name Time Method Adverse events Laboratory data Vital signs Study drug exposure Behavioral/cognitive assessments
Trial Locations
- Locations (1)
Global Medical Information - Abbott
🇺🇸North Chicago, Illinois, United States