Status:
COMPLETED
A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488.
Lead Sponsor:
Abbott
Conditions:
Migraines
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
- 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;
- The subject was randomized into Study M02-488 and either completed the study or prematurely discontinued due to ineffectiveness; and
- The subject is male or non-pregnant, non-lactating female
- Exclusion Criteria
- Female, of childbearing potential, and not using an effective method of birth control (e.g., total sexual abstinence or contraceptives).
- Experienced a serious adverse event in Study M02-488 which the investigator considered "possibly" or "probably related" to study drug; or
- In the investigator's opinion, long-term treatment with Depakote ER for migraine prophylaxis is contraindicated.
- For any reason, subject is considered by the investigator to be an unsuitable candidate to receive divalproex sodium or to participate in this study.
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00195754
Start Date
July 1 2004
Last Update
July 31 2007
Active Locations (1)
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1
Global Medical Information - Abbott
North Chicago, Illinois, United States, 60064