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

Epilepsy Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347152
• Other study ID #: 10399
• Status: Completed
• Phase: N/A
• First received: June 30, 2006
• Last updated: September 10, 2008
• Start date: November 2006
• Est. completion date: December 2007

Study information

• Verified date: September 2008
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Intellectual Disability

Intervention

Drug:
• Divalproex
Divalproex, 8-20% taper
• Divalproex
Divalproex, 8-20% taper

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Baseline to day +8	Yes
Secondary	seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;		Baseline to day + 8	Yes
Secondary	total valproic acid serum levels (trough of pre-dose measurements)		Prior to conversion, 1 week post conversion	Yes
Secondary	changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel		Prior to and one week post conversion	Yes