Tolerability and Efficacy of Depakote-extended Release in the Elderly
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tolerability and Efficacy of Depakote-ER in the Elderly|
- Effectiveness of Medication as Measured by Participation Through the End of the Trial. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Number of participants completing the trial
- Patient's Compliance With Once a Day Dosing. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Subjects pill count for once a day dosing and compliance with medication as a percent of total doses prescribed.
- Number of Seizures Per Month [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Count of seizures per month determined by seizures recorded in diaries.
- Change From Baseline as Measured by the Seizure Severity Questionnaire (SSQ) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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
|Study Start Date:||April 2006|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Drug: Divalproex Sodium Extended-Release Tablets
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318929
|United States, Virginia|
|Virginia Commonwealth University Medical Center, Department of Neurology|
|Richmond, Virginia, United States, 23219|
|Principal Investigator:||Alan R Towne, M.D.||Virginia Commonwealth University|