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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2006 by Veterans Affairs Medical Center, Miami.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: April 10, 2006
Last Update Posted: April 10, 2006
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.
Information provided by:
Veterans Affairs Medical Center, Miami
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 Intervention Phase
Epilepsy Behavioral Disturbance Procedure: Rapid versus slow conversion Phase 4

Study Type: Interventional
Study Design: 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:

Resource links provided by NLM:

Further study details as provided by Veterans Affairs Medical Center, Miami:

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

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

Estimated Enrollment: 20
Study Start Date: March 2006
Estimated Study Completion Date: October 2006
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00312676

Contact: Renato Seguro, MD 305-575-7000 ext 6033 wallace3299@epiworld.com
Contact: Trichia Ramsay 305-575-7000 ext 3963 trichia@epiworld.com

United States, Florida
Miami VA Medical Center Recruiting
Miami, Florida, United States, 33125
Contact: R. Eugene Ramsay, MD    305-575-3192    eramsay@epiworld.com   
Principal Investigator: R. Eugene Ramsay, MD         
Sponsors and Collaborators
Veterans Affairs Medical Center, Miami
Principal Investigator: R. Eugene Ramsay, MD Miami Veterans Administration Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00312676     History of Changes
Other Study ID Numbers: 7332.55b
First Submitted: April 6, 2006
First Posted: April 10, 2006
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:
Problem Behavior
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms
Valproic Acid
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