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

Primary Purpose

Epilepsy, Behavioral Disturbance

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Rapid versus slow conversion

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Tolerability, Depakote DR, Depakote ER, Elderly, Conversion

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 60 yo and older on stable dose of valproate (Depakote DR) Exclusion Criteria: Unstable neurolgical, medical or psychiatric disorder

Sites / Locations

Miami VA Medical CenterRecruiting

Outcomes

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

Full Information

NCT ID

NCT00312676

First Posted

April 6, 2006

Last Updated

April 6, 2006

Sponsor

Veterans Affairs Medical Center, Miami

Collaborators

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00312676

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2006

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Veterans Affairs Medical Center, Miami

Collaborators

Abbott

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epilepsy, Behavioral Disturbance

Keywords

Tolerability, Depakote DR, Depakote ER, Elderly, Conversion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Rapid versus slow conversion

Primary Outcome Measure Information:

Title

Between group comparisons of GI and CNS side effect burden

Secondary Outcome Measure Information:

Title

Between group comparison of Quality of Life as measured bye the QOLIE-89

Title

Between group comparison of trough Total and Free valproic acid serum levels

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 60 yo and older on stable dose of valproate (Depakote DR) Exclusion Criteria: Unstable neurolgical, medical or psychiatric disorder

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Renato Seguro, MD

Phone

305-575-7000

Ext

6033

wallace3299@epiworld.com

First Name & Middle Initial & Last Name or Official Title & Degree

Trichia Ramsay

Phone

305-575-7000

Ext

3963

trichia@epiworld.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

R. Eugene Ramsay, MD

Organizational Affiliation

Miami Veterans Administration Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Miami VA Medical Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

R. Eugene Ramsay, MD

Phone

305-575-3192

eramsay@epiworld.com

First Name & Middle Initial & Last Name & Degree

R. Eugene Ramsay, MD

12. IPD Sharing Statement

Learn more about this trial

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

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