Tolerability and Efficacy of Depakote-extended Release in the Elderly

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Abbott
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Is > 60 years of age (male or female)

• Has a confirmed diagnosis of epilepsy with partial seizures

• Has one of the following

1. newly diagnosed partial seizures

2. has inadequately controlled partial seizures, i.e. continues to have seizure activity while on his/her medication regimen

3. 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

• 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:

• 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

• 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