Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote
- Conditions
- EpilepsyBehavioral Disturbance
- Registration Number
- NCT00312676
- Lead Sponsor
- Veterans Affairs Medical Center, Miami
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 60 yo and older on stable dose of valproate (Depakote DR)
- Unstable neurolgical, medical or psychiatric disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Between group comparisons of GI and CNS side effect burden
- Secondary Outcome Measures
Name Time Method Between group comparison of Quality of Life as measured bye the QOLIE-89 Between group comparison of trough Total and Free valproic acid serum levels
Trial Locations
- Locations (1)
Miami VA Medical Center
🇺🇸Miami, Florida, United States