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Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312676
Recruitment Status : Unknown
Verified March 2006 by Veterans Affairs Medical Center, Miami.
Recruitment status was:  Recruiting
First Posted : April 10, 2006
Last Update Posted : April 10, 2006
Information provided by:
Veterans Affairs Medical Center, Miami

Brief Summary:
The hypothesis is that the characteristics of extended release Depakote will allow overnight conversion of immediate release to extended release form of Depakote. This has been tested successfully in younger patients but not in individuals over the age of 60. We will include individuals between 60 and 80 years old.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral Disturbance Procedure: Rapid versus slow conversion Phase 4

Detailed Description:
Twenty patients will be randomily assigned to convert overnight (10 pts) or over six days (10 pts). Side effects will be formally evaluated by the UKU side effect rating scal which will be done 7 days before conversion (day -7), the day of conversion (day 0)and then at the start of days +2, +7 and +14. This investigator conducting the evaluation will be blinded to the conversion status of the patient. Secondary measures to be obtained will be a Quality of Life measure (QOLIE-89) on Day 0 and +14. Plasma samples will be obtained on Day 0 and +14 before dosing for total and free valproic blood level.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances:
Study Start Date : March 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Primary Outcome Measures :
  1. Between group comparisons of GI and CNS side effect burden

Secondary Outcome Measures :
  1. Between group comparison of Quality of Life as measured bye the QOLIE-89
  2. Between group comparison of trough Total and Free valproic acid serum levels

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 60 yo and older on stable dose of valproate (Depakote DR)

Exclusion Criteria:

  • Unstable neurolgical, medical or psychiatric disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312676

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Contact: Renato Seguro, MD 305-575-7000 ext 6033
Contact: Trichia Ramsay 305-575-7000 ext 3963

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United States, Florida
Miami VA Medical Center Recruiting
Miami, Florida, United States, 33125
Contact: R. Eugene Ramsay, MD    305-575-3192   
Principal Investigator: R. Eugene Ramsay, MD         
Sponsors and Collaborators
Veterans Affairs Medical Center, Miami
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Principal Investigator: R. Eugene Ramsay, MD Miami Veterans Administration Medical Center
Layout table for additonal information Identifier: NCT00312676    
Other Study ID Numbers: 7332.55b
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: April 10, 2006
Last Verified: March 2006
Keywords provided by Veterans Affairs Medical Center, Miami:
Depakote DR
Depakote ER
Additional relevant MeSH terms:
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Problem Behavior
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms