Back to resultsComparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Divalproex
Divalproex
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Intellectual disabilities, development disabilities, behavior disorders, stable epilepsy
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2
1
Arm Description
Slow Progressive Divalproex DR to Divalproex ER switch
Immediate, Progressive Divalproex DR to Divalproex ER switch
Outcomes
Primary Outcome Measures
direct observation of side effects by staff and investigator, side effect ratings using the MOSES side effect rating scale post-switch. (Multidimensional observational scale for elderly subjects)
Secondary Outcome Measures
seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;
total valproic acid serum levels (trough of pre-dose measurements)
changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel
Full Information
NCT ID
NCT00347152
First Posted
June 30, 2006
Last Updated
September 10, 2008
Sponsor
University of Kansas
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00347152
Brief Title
Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability
Official Title
Overnight Versus Progressive Conversion of Multiple Daily Dose Enteric-Coated Divalproex to Once-Daily Divalproex Extended Release: Which Strategy is Better Tolerated by Patients With Intellectual Disabilities?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Kansas
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 are switched to the extended release form (ER) overnight versus when they switch more gradually over a week.
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 determine the best method of conversion from multiple-daily dose delayed release depakote to once-daily for subjects with epilepsy bipolar disorder or behavior disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Intellectual disabilities, development disabilities, behavior disorders, stable epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Slow Progressive Divalproex DR to Divalproex ER switch
Arm Title
1
Arm Type
Active Comparator
Arm Description
Immediate, Progressive Divalproex DR to Divalproex ER switch
Intervention Type
Drug
Intervention Name(s)
Divalproex
Other Intervention Name(s)
Depakote
Intervention Description
Divalproex, 8-20% taper
Intervention Type
Drug
Intervention Name(s)
Divalproex
Other Intervention Name(s)
Depakote
Intervention Description
Divalproex, 8-20% taper
Primary Outcome Measure Information:
Title
direct observation of side effects by staff and investigator, side effect ratings using the MOSES side effect rating scale post-switch. (Multidimensional observational scale for elderly subjects)
Time Frame
Baseline to day +8
Secondary Outcome Measure Information:
Title
seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;
Time Frame
Baseline to day + 8
Title
total valproic acid serum levels (trough of pre-dose measurements)
Time Frame
Prior to conversion, 1 week post conversion
Title
changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel
Time Frame
Prior to and one week post conversion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Hellings, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability
We'll reach out to this number within 24 hrs