NCT00312676

Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote

Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances:

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Veterans Affairs Medical Center, Miami · Federal
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Behavioral Disturbance

Interventions

Type	Name	Description
PROCEDURE	Rapid versus slow conversion

Timeline

• Start date: 2006-03-01
• Completion: 2006-10-01
• First posted: 2006-04-10
• Last updated: 2006-04-10

Locations

1 site across 1 country: United States