Status:
COMPLETED
Compliance With Once-Daily Divalproex Extended-Release Tablets (Depakote-ER) Versus Multiple-Daily Dose Valproic Acid Capsules (Depakene) in Epilepsy:
Lead Sponsor:
Orlando Health, Inc.
Collaborating Sponsors:
Abbott
Conditions:
Epilepsy
Eligibility:
All Genders
16-99 years
Brief Summary
To determine, in a randomized, parallel open-label fashion, compliance rates between once-daily extended-release divalproex sodium tablets (Depakote-ER®, Abbott Labs) versus multiple-daily dose valpro...
Detailed Description
x\_ Prospective x\_\_ Single-center \_\_ Multicenter x\_\_ Open-label \_\_ Double-blind \_\_ Single-blind x\_ Randomized (please provide randomization ratio): 1:1 This population includes both patient...
Eligibility Criteria
Inclusion
- 1) Patients, age 16 and above, currently taking Divalproex-DR for any seizure disorder; 2) Other AEDs are permitted concurrently, although compliance with these will not be recorded. Other medications for co-morbid disease are permitted, provided no plans for changes in medications used for the treatment of the concomitant disorder are expected.
- 3\) Patients must demonstrate a 75% or greater compliance rate with DR via calendar during the week of familiarity with the MEMs unit. The threshold value of 75% has been chosen since research shows that people take approximately 75% of their AED(s) as prescribed (13,14), and the same numerical value is frequently used in determining whether or not to retain a patient in clinical Phase 2a-3b industry-sponsored study.
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Exclusion
- 1) patients with a recent history of status epilepticus; 2) patients who have refractory or unstable epilepsy; 3) patients with acute illnesses requiring changes in concurrent drugs; 4) patients unwilling to change from their present DR regimen to divalproex-ER or IR-VPA.
- 5\) Patients unwilling or unable to utilize the MEMs monitoring unit; 6) Pregnant or lactating women.
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Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00356018
Start Date
July 1 2006
End Date
May 1 2007
Last Update
March 4 2020
Active Locations (1)
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1
Orlando Regional Lucerne Hospital
Orlando, Florida, United States, 32801