• To assess the effectiveness, i.e. the efficacy and tolerability, of Depakote-ER (controlled release sodium divalproex) in elderly patients with epilepsy. Effectiveness will be measured by survival in the study, i.e. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  

• Patient's preference and adherence for once versus twice a day dosing [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  
• Change from baseline in quality of life as measured by the QUOLIE - 31 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  
• Change from baseline in depression as measured by the Beck's Depression Inventory [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  

Drug: Divalproex Sodium Extended-Release Tablets
Once a day dosing

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 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.