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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
University of Kansas
ClinicalTrials.gov Identifier:
NCT00347152
First received: June 30, 2006
Last updated: September 10, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Epilepsy
Drug: Divalproex

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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?

Resource links provided by NLM:


Further study details as provided by University of Kansas:

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) [ Time Frame: Baseline to day +8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • total valproic acid serum levels (trough of pre-dose measurements) [ Time Frame: Prior to conversion, 1 week post conversion ] [ Designated as safety issue: Yes ]
  • changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel [ Time Frame: Prior to and one week post conversion ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: November 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Slow Progressive Divalproex DR to Divalproex ER switch
Drug: Divalproex
Divalproex, 8-20% taper
Other Name: Depakote
Active Comparator: 1
Immediate, Progressive Divalproex DR to Divalproex ER switch
Drug: Divalproex
Divalproex, 8-20% taper
Other Name: Depakote

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347152

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Abbott
Investigators
Principal Investigator: Jessica Hellings, MD University of Kansas
  More Information

No publications provided

Responsible Party: Jessica Hellings, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00347152     History of Changes
Other Study ID Numbers: 10399
Study First Received: June 30, 2006
Last Updated: September 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kansas:
Intellectual disabilities
development disabilities
behavior disorders
stable epilepsy

Additional relevant MeSH terms:
Epilepsy
Intellectual Disability
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Mental Disorders Diagnosed in Childhood
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 20, 2014