Status:
COMPLETED
Study Designed to Evaluate the Safety of Prophylactic Depakote ER in the Treatment of Adolescents With Migraine
Lead Sponsor:
Abbott
Conditions:
Migraine
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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:
- Platelet count =/\< 100,000/uL
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT00195806
Start Date
February 1 2005
Last Update
September 3 2007
Active Locations (1)
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1
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064