Migraine
Conditions
Keywords
Migraine, Depakote ER, Divalproex sodium
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.
Interventions
DRUGdivalproex sodium
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of migraine headache days | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
| Laboratory data | — |
| Vital signs | — |
| Study drug exposure | — |
| Behavioral/cognitive assessments | — |
Countries
United States
Outcome results
None listed