An interventional study of Divalproex Sodium Extended-Release Tablets in Elderly, Epilepsy and Seizures, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2018-02-05.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Treatment
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.
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.
881 studies on the registry are indexed under Seizures; 144 are open to participants now.
This study's enrollment of 14 is below the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Has one of the following
Exclusion Criteria:
Once a day dosing
Effectiveness of Medication as Measured by Participation Through the End of the Trial.
Number of participants completing the trial
Time frame: 24 weeks
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.
Time frame: 24 weeks
Number of Seizures Per Month
Count of seizures per month determined by seizures recorded in diaries.
Time frame: 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
Time frame: 24 weeks
Recruitment began April 2006 and completed January 2008. Subjects were seen in an outpatient clinic
| Milestone | Depakote ER |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
Number of participants completing the trial
| participants | Depakote ER |
|---|---|
| Effectiveness of Medication as Measured by Participation Through the End of the Trial. | 14 |
Subjects pill count for once a day dosing and compliance with medication as a percent of total doses prescribed.
No measurements were reported for this outcome.
Count of seizures per month determined by seizures recorded in diaries.
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Depakote ER | — | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Depakote ER |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 2 |
| Age, Continuous(years) | Depakote ER |
|---|---|
| Mean | 66.1 ± 9.5 |
| Sex: Female, Male(Participants) | Depakote ER |
|---|---|
| Female | 3 |
| Male | 11 |
| Region of Enrollment(participants) | Depakote ER |
|---|---|
| United States | 14 |
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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