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Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote - NCT00312676-33125(Clinical Trial 140678)



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City:  Miami
State:  
FL
Zip Code: 33125
Conditions: Epilepsy - Behavioral Disturbance
Purpose: The hypothesis is that the characteristics of extended release Depakote will allow overnight conversion of immediate release to extended release form of Depakote. This has been tested successfully in younger patients but not in individuals over the age of 60. We will include individuals between 60 and 80 years old.
Study summary: Twenty patients will be randomily assigned to convert overnight (10 pts) or over six days (10 pts). Side effects will be formally evaluated by the UKU side effect rating scal which will be done 7 days before conversion (day -7), the day of conversion (day 0)and then at the start of days +2, +7 and +14. This investigator conducting the evaluation will be blinded to the conversion status of the patient. Secondary measures to be obtained will be a Quality of Life measure (QOLIE-89) on Day 0 and +14. Plasma samples will be obtained on Day 0 and +14 before dosing for total and free valproic blood level.
Criteria: Inclusion Criteria: - 60 yo and older on stable dose of valproate (Depakote DR) Exclusion Criteria: - Unstable neurolgical, medical or psychiatric disorder
Study is available at: Miami VA Medical Center
Miami, FL 33125
United States

Primary Contact:
R. Eugene Ramsay, MD
Email: eramsay@epiworld.com
Phone: 305-575-3192

Secondary Contact:
Renato Seguro, MD
Email: wallace3299@epiworld.com
Phone: 305-575-7000
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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