Status:
COMPLETED
Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability
Lead Sponsor:
University of Kansas
Collaborating Sponsors:
Abbott
Conditions:
Epilepsy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether there is any difference in side effects experienced by individuals with intellectual disorders taking Depakote DR (immediate release form) when they a...
Detailed Description
Considering that there are potential advantages to once-daily depakote extended release in terms of decreased side effects, decreased medication errors and patient compliance, there is a need to deter...
Eligibility Criteria
Inclusion
- patients currently taking divalproex direct release for any seizure and/or behavior disorder
- patients with intellectual disability
- other medications for co-morbid disease are permitted, provided no plans for changes in medication used for the treatment of the disorder are expected
Exclusion
- patients with a recent history of status epilepticus in the past 6 months
- seizures in the past 3 months
- patients with acute illness requiring changes in concurrent drugs
- patients unwilling to change from their present direct release divalproex to divalproex extended release
- patients that do not have a reliable caregiver
- patients with lack of verbal expressive speech
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00347152
Start Date
November 1 2006
End Date
December 1 2007
Last Update
September 12 2008
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160