Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote
Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances:
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 6, 2006
CompletedFirst Posted
Study publicly available on registry
April 10, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedApril 10, 2006
March 1, 2006
April 6, 2006
April 6, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Between group comparisons of GI and CNS side effect burden
Secondary Outcomes (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- yo and older on stable dose of valproate (Depakote DR)
You may not qualify if:
- Unstable neurolgical, medical or psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Veterans Affairs Medical Center, Miamilead
- Abbottcollaborator
Study Sites (1)
Miami VA Medical Center
Miami, Florida, 33125, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
R. Eugene Ramsay, MD
Miami Veterans Administration Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
April 6, 2006
First Posted
April 10, 2006
Study Start
March 1, 2006
Study Completion
October 1, 2006
Last Updated
April 10, 2006
Record last verified: 2006-03