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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Veterans Affairs Medical Center, Miami.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Veterans Affairs Medical Center, Miami
ClinicalTrials.gov Identifier:
NCT00312676
First received: April 6, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable neurolgical, medical or psychiatric disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312676

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

Locations
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
Abbott
Investigators
Principal Investigator: R. Eugene Ramsay, MD Miami Veterans Administration Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00312676     History of Changes
Other Study ID Numbers: 7332.55b
Study First Received: April 6, 2006
Last Updated: April 6, 2006
Health Authority: United States: Federal Government

Keywords provided by Veterans Affairs Medical Center, Miami:
Tolerability
Depakote DR
Depakote ER
Elderly
Conversion

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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 April 15, 2014