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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances:
- ClinicalTrials.gov ID
- NCT00312676
- Acronym / sponsor ID
- 7332.55b
- Conditions
- Epilepsy, Behavioral Disturbance
- Keywords
- Tolerability, Depakote DR, Depakote ER, Elderly, Conversion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Veterans Affairs Medical Center, MiamiUS federal agency
- Collaborators
- Abbott
- Study start
- Mar 2006
- Study completion
- Oct 2006
- First posted
- 10 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60 yo and older on stable dose of valproate (Depakote DR)
Key exclusion criteria (1 listed)
- Unstable neurolgical, medical or psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid versus slow conversion | Procedure or surgery | – |
Primary outcome
Between group comparisons of GI and CNS side effect burden
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Eugene Ramsay, MD principal investigator
Miami Veterans Administration Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renato Seguro, MD (305-575-7000 ext. 6033, wallace3299@epiworld.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between group comparisons of GI and CNS side effect burden. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2006.