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.
Phase 3
Completed
- Conditions
- Migraines
- Registration Number
- NCT00195754
- 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
- 114
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety outcome measure 12 months
- Secondary Outcome Measures
Name Time Method Migraine headache rate 12 months
Trial Locations
- Locations (1)
Global Medical Information - Abbott
🇺🇸North Chicago, Illinois, United States