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

NCT00347152 | Completed

• 1 other identifier: 10399
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Intellectual disabilities; development disabilities; behavior disorders; stable epilepsy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• seizures observed, compared with prior rate of seizures;maintenance of clinical response using the Clinical Global Impressions Scale-improvement subscale;

  Baseline to day + 8

• total valproic acid serum levels (trough of pre-dose measurements)

  Prior to conversion, 1 week post conversion

• changes in blood work, including CBC, platelet counts, LFT, serum chemistry panel

  Prior to and one week post conversion

Study Arms (2)

2

ACTIVE COMPARATOR

Slow Progressive Divalproex DR to Divalproex ER switch

Drug: Divalproex

1

ACTIVE COMPARATOR

Immediate, Progressive Divalproex DR to Divalproex ER switch

Drug: Divalproex

Interventions

Divalproex DRUG

Divalproex, 8-20% taper

Also known as: Depakote

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas: lead
• Abbott: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Epilepsy; Intellectual Disability; Mental Disorders

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Jessica Hellings, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: September 12, 2008

Record last verified: 2008-09

Locations

US (1)