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

April 6, 2006 updated by: Veterans Affairs Medical Center, Miami

Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances:

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33125
        • Recruiting
        • Miami VA Medical Center
        • Contact:
        • Principal Investigator:
          • R. Eugene Ramsay, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unstable neurolgical, medical or psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Between group comparisons of GI and CNS side effect burden

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veterans Affairs Medical Center, Miami

Collaborators

Abbott

Investigators

  • Principal Investigator: R. Eugene Ramsay, MD, Miami Veterans Administration Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

April 6, 2006

First Submitted That Met QC Criteria

April 6, 2006

First Posted (Estimate)

April 10, 2006

Study Record Updates

Last Update Posted (Estimate)

April 10, 2006

Last Update Submitted That Met QC Criteria

April 6, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7332.55b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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