Status:
COMPLETED
Tolerability and Efficacy of Depakote-extended Release in the Elderly
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Abbott
Conditions:
Elderly
Epilepsy
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 elde...
Detailed Description
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 elde...
Eligibility Criteria
Inclusion
- Is \> 60 years of age (male or female)
- Has a confirmed diagnosis of epilepsy with partial seizures
- Has one of the following
- newly diagnosed partial seizures
- has inadequately controlled partial seizures, i.e. continues to have seizure activity while on his/her medication regimen
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00318929
Start Date
April 1 2006
End Date
January 1 2008
Last Update
February 5 2018
Active Locations (1)
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1
Virginia Commonwealth University Medical Center, Department of Neurology
Richmond, Virginia, United States, 23219