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.
This study has been completed.
Information provided by:
First received: September 13, 2005
Last updated: July 30, 2007
Last verified: July 2007
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Abbott:
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195754
|United States, Illinois|
|Global Medical Information - Abbott|
|North Chicago, Illinois, United States, 60064|
Sponsors and Collaborators
|Study Director:||Global Medical Information 800-633-9110||Abbott|