EpilepsyPhase 4NCT00312676
Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote
A Phase 4 study testing Rapid versus slow conversion in people with Epilepsy and Behavioral Disturbance, run by Veterans Affairs Medical Center, Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Epilepsy, Behavioral Disturbance
- What is being tested?
- Rapid versus slow conversion
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2006
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 yo and older on stable dose of valproate (Depakote DR)
Who cannot join
- Unstable neurolgical, medical or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Miami VA Medical Center
Miami, Florida, 33125
R. Eugene Ramsay, MD, 305-575-3192, eramsay@epiworld.com
R. Eugene Ramsay, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy, Behavioral Disturbance
- Being tested
- Rapid versus slow conversion
- Keywords
- Tolerability, Depakote DR, Depakote ER, Elderly, Conversion
- Medical subject headings
- Epilepsy, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid versus slow conversionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startMar 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Veterans Affairs Medical Center, Miami
- Sponsor type
- US federal agency
- Collaborators
- Abbott
- Investigators
- R. Eugene Ramsay, MD, Principal investigator, Miami Veterans Administration Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312676
- Sponsor's protocol ID
- 7332.55b
- Status last verified
- Mar 2006
- First submitted
- 6 Apr 2006
- Last updated
- 10 Apr 2006
- Results posted
- No