Expired Study
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North Chicago, Illinois 60064


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.


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.


NCT ID:

NCT00195806


Primary Contact:

Study Director
Global Medical Information 800-633-9110
Abbott


Backup Contact:

N/A


Location Contact:

North Chicago, Illinois 60064
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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