ElderlyNCT00318929
Tolerability and Efficacy of Depakote-extended Release in the Elderly
A study testing Divalproex Sodium Extended-Release Tablets in people with Elderly and Epilepsy, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient… Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Divalproex Sodium Extended-Release Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is > 60 years of age (male or female)
- Has a confirmed diagnosis of epilepsy with partial seizures
- Has one of the following
- newly diagnosed partial seizures
- has inadequately controlled partial seizures, i.e. continues to have seizure activity while on his/her medication regimen
- is taking Depakote twice a day for partial seizures but is having side effects or problems with adherence and may benefit from once a day dosing
Show all 11Show fewer
- Is able and willing to maintain an accurate, complete, written daily seizure diary
- Is able and willing to complete the QOLIE, the Beck Depression Inventory, and the SSQ
- Is able to given written informed consent
- Is compliant with clinic visits
- Is able to swallow Depakote-ER
Who cannot join
- Has had status epilepticus in the 24 weeks prior to the Baseline Phase of the Study
- Is taking three or more AEDs chronically
- Is currently abusing alcohol and/or any other substance
- Has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study
- Is receiving any medication that could influence seizure control
- Is currently following the ketogenic diet
Show all 10Show fewer
- Is planning surgery or the insertion of the vagal nerve stimulator for seizure control during the course of the study.
- Is suffering from acute or progressive neurologic disease, severe psychiatric disease, or severe mental abnormality that are likely to interfere with the objectives of the study
- Has any clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs.
- Baseline elevations of LFTs more than 3 times normal, clinically elevated amylase, and clinically significant thrombocytopenia
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Medical Center, Department of Neurology
Richmond, Virginia, 23219
About this study
Official title: Tolerability and Efficacy of Depakote-ER in the Elderly
There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient ischemic attacks. However, the consequences of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic and pharmacodynamic changes occurring in the elderly.
Read the detailed description
There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient ischemic attacks. However, the consequences of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic and pharmacodynamic changes occurring in the elderly.
Three Veterans Cooperative trials evaluating antiepileptic drug (AED) therapy in the elderly demonstrated that the ability to tolerate the AED is a more determining factor for long term success than the ability to suppress seizure activity. In general, elderly patients appear more intolerable to medications. This may stem from co-morbid conditions, concurrent medications, pharmacokinetic changes, and/or pharmacodynamic changes. Therefore, it is important to study the efficacy and tolerability of AEDs in the elderly.
Valproic acid has been available for the treatment of partial and generalized seizures since 1978. Sodium divalproex is metabolized in the gut to valproic acid. Depakote and Depakote-ER (extended release)are among the dosage forms of sodium divalproex. Depakote is an enteric coated tablet that is designed to dissolve in the more alkaline milieu of the small intestine rather than the more acidic milieu of the stomach. This helps the drug to bypass the stomach and reduces gastrointestinal distress. Once the enteric coating dissolves, the sodium divalproex is metabolized to valproic acid and rapidly absorbed. Depakote is administered twice a day. Depakote-ER is a controlled release drug delivery system designed to release drug over a 22 hour period which allows for once a day dosing. The efficacy and tolerability of Depakote-ER has not been described in elderly patients with epilepsy.
- Being tested
- Divalproex Sodium Extended-Release Tablets
- Keywords
- Treatment Efficacy, pharmacokinetics
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex Sodium Extended-Release TabletsDrug
Once a day dosing
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Medication as Measured by Participation Through the End of the Trial.
Number of participants completing the trial
Measured: 24 weeks
Secondary outcomes (3)
Patient's Compliance With Once a Day Dosing.
Subjects pill count for once a day dosing and compliance with medication as a percent of total doses prescribed.
Measured: 24 weeks
Number of Seizures Per Month
Count of seizures per month determined by seizures recorded in diaries.
Measured: 24 weeks
Change From Baseline as Measured by the Seizure Severity Questionnaire (SSQ)
Seizure Severity Questionnaire summary score, on a scale of 1 to 7 with one being the least severe and 7 being the most severe, components of seizures include; warning, activity and recovery
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Alan R Towne, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318929
- Sponsor's protocol ID
- VCUHM10204
- Status last verified
- Jan 2018
- First submitted
- 25 Apr 2006
- Last updated
- 5 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Efficacy of Depakote-ER in the Elderly
- ClinicalTrials.gov ID
- NCT00318929
- Acronym / sponsor ID
- VCUHM10204
- Keywords
- Treatment Efficacy, pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Apr 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Posted 9 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient ischemic attacks. However, the consequences of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic and pharmacodynamic changes occurring in the elderly.
Detailed description
There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient ischemic attacks. However, the consequences of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic and pharmacodynamic changes occurring in the elderly.
Three Veterans Cooperative trials evaluating antiepileptic drug (AED) therapy in the elderly demonstrated that the ability to tolerate the AED is a more determining factor for long term success than the ability to suppress seizure activity. In general, elderly patients appear more intolerable to medications. This may stem from co-morbid conditions, concurrent medications, pharmacokinetic changes, and/or pharmacodynamic changes. Therefore, it is important to study the efficacy and tolerability of AEDs in the elderly.
Valproic acid has been available for the treatment of partial and generalized seizures since 1978. Sodium divalproex is metabolized in the gut to valproic acid. Depakote and Depakote-ER (extended release)are among the dosage forms of sodium divalproex. Depakote is an enteric coated tablet that is designed to dissolve in the more alkaline milieu of the small intestine rather than the more acidic milieu of the stomach. This helps the drug to bypass the stomach and reduces gastrointestinal distress. Once the enteric coating dissolves, the sodium divalproex is metabolized to valproic acid and rapidly absorbed. Depakote is administered twice a day. Depakote-ER is a controlled release drug delivery system designed to release drug over a 22 hour period which allows for once a day dosing. The efficacy and tolerability of Depakote-ER has not been described in elderly patients with epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Is > 60 years of age (male or female)
- Has a confirmed diagnosis of epilepsy with partial seizures
- Has one of the following
- Is able and willing to maintain an accurate, complete, written daily seizure diary
- Is able and willing to complete the QOLIE, the Beck Depression Inventory, and the SSQ
Key exclusion criteria (10 listed)
- Has had status epilepticus in the 24 weeks prior to the Baseline Phase of the Study
- Is taking three or more AEDs chronically
- Is currently abusing alcohol and/or any other substance
- Has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study
- Is receiving any medication that could influence seizure control
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 |
|---|---|---|
| Divalproex Sodium Extended-Release TabletsOnce a day dosing | Drug | – |
Primary outcome
Effectiveness of Medication as Measured by Participation Through the End of the Trial.
Time frame: 24 weeks
Number of participants completing the trial
3 secondary outcomes
Patient's Compliance With Once a Day Dosing.
Time frame: 24 weeks
Number of Seizures Per Month
Time frame: 24 weeks
Change From Baseline as Measured by the Seizure Severity Questionnaire (SSQ)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alan R Towne, M.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Divalproex Sodium Extended-Release Tablets in people with Elderly and Epilepsy, run by Virginia Commonwealth University 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 11 inclusion and 10 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: finished, as of the sponsor's last update on 5 Feb 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Medication as Measured by Participation Through the End of the Trial. (time frame: 24 weeks). 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 5 Feb 2018.