Tolerability and Efficacy of Depakote-extended Release in the Elderly

NCT00318929 | Completed Results

• 1 other identifier: VCUHM10204
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Elderly; Epilepsy; Seizures

Keywords

Treatment Efficacy; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Medication as Measured by Participation Through the End of the Trial.

  Number of participants completing the trial

  24 weeks

Secondary Outcomes (3)

• Patient's Compliance With Once a Day Dosing.

  24 weeks

• Number of Seizures Per Month

  24 weeks

• Change From Baseline as Measured by the Seizure Severity Questionnaire (SSQ)

  24 weeks

Interventions

Divalproex Sodium Extended-Release Tablets DRUG

Once a day dosing

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Abbott: collaborator

Study Sites (1)

Virginia Commonwealth University Medical Center, Department of Neurology

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alan R. Towne, MD
• Organization: Virginia Commonwealth University

atowne@mcvh-vcu.edu

804-282-9869

Study Officials

• Alan R Towne, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: February 5, 2018
• Results First Posted: July 9, 2010

Record last verified: 2018-01

Locations

US (1)