Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability

September 10, 2008 updated by: University of Kansas

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Slow Progressive Divalproex DR to Divalproex ER switch
Drug: Divalproex
Divalproex, 8-20% taper
Other Names:
  • Depakote
Active Comparator: 1
Immediate, Progressive Divalproex DR to Divalproex ER switch
Drug: Divalproex
Divalproex, 8-20% taper
Other Names:
  • Depakote

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to day +8

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to day + 8
total valproic acid serum levels (trough of pre-dose measurements)
Time Frame: Prior to conversion, 1 week post conversion
Prior to conversion, 1 week post conversion
changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel
Time Frame: Prior to and one week post conversion
Prior to and one week post conversion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Collaborators

Abbott

Investigators

  • Principal Investigator: Jessica Hellings, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

September 12, 2008

Last Update Submitted That Met QC Criteria

September 10, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10399 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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