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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex Sodium Extended-Release Tablets | Drug | Once a day dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Medication as Measured by Participation Through the End of the Trial. | Number of participants completing the trial | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Number of Seizures Per Month |
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Inclusion Criteria:
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
Is able to given written informed consent
Is compliant with clinic visits
Is able to swallow Depakote-ER
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan R Towne, M.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University Medical Center, Department of Neurology | Richmond | Virginia | 23219 | United States |
Subjects recruited had either inadequately controlled seizures or were taking Depakote twice a day.
Recruitment began April 2006 and completed January 2008. Subjects were seen in an outpatient clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Depakote ER | Dosing regimen from 750 to 1250 mg once a day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Depakote ER | Dosing regimen from 750 to 1250 mg once a day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness of Medication as Measured by Participation Through the End of the Trial. | Number of participants completing the trial | Posted | Number | participants | 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Depakote ER | Dosing regimen from 750 to 1250 mg once a day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan R. Towne, MD | Virginia Commonwealth University | 804-282-9869 | atowne@mcvh-vcu.edu |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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Count of seizures per month determined by seizures recorded in diaries.
| 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 | 24 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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. | Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results. | Posted | 24 weeks |
|
|
| Secondary | Number of Seizures Per Month | Count of seizures per month determined by seizures recorded in diaries. | Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results. | Posted | 24 weeks |
|
|
| Secondary | 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 | Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results. | Posted | 24 weeks |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |