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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00312676
• Other study ID #: 7332.55b
• Status: Recruiting
• Phase: Phase 4
• First received: April 6, 2006
• Last updated: April 6, 2006
• Start date: March 2006
• Est. completion date: October 2006

Study information

• Verified date: March 2006
• Source: Veterans Affairs Medical Center, Miami
• Contact: Renato Seguro, MD
• Phone: 305-575-7000
• Email: wallace3299[@]epiworld.com
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Unstable neurolgical, medical or psychiatric disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavioral Disturbance
• Epilepsy
• Mental Disorders

Intervention

Procedure:
• Rapid versus slow conversion

Locations

Country	Name	City	State
United States	Miami VA Medical Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Veterans Affairs Medical Center, Miami	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between group comparisons of GI and CNS side effect burden
Secondary	Between group comparison of Quality of Life as measured bye the QOLIE-89
Secondary	Between group comparison of trough Total and Free valproic acid serum levels