Compliance With Once-Daily Divalproex Extended-Release Tablets (Depakote-ER) Versus Multiple-Daily Dose Valproic Acid Capsules (Depakene) in Epilepsy:

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Orlando Health, Inc.
ClinicalTrials.gov Identifier:
NCT00356018
First received: July 21, 2006
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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 valproic acid capsules (Depakene®, Abbott Labs) in an epilepsy population.


Condition Intervention Phase
Epilepsy
Behavioral: Compliance
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Compliance With Once-Daily Divalproex Extended-Release Tablets (Depakote-ER) Versus Multiple-Daily Dose Valproic Acid Capsules (Depakene) in Epilepsy: A Randomized, Parallel, Prospectively-Controlled Outpatient Comparison

Resource links provided by NLM:


Further study details as provided by Orlando Health, Inc.:

Enrollment: 5
Study Start Date: July 2006
Study Completion Date: February 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The population includes both patients whose seizures are relatively well controlled on their present conventional, enteric-coated twice-daily or three-times daily Divalproex sodium regimen.

Criteria

Inclusion Criteria: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 Criteria: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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356018

Locations
United States, Florida
Orlando Regional Lucerne Hospital
Orlando, Florida, United States, 32801
Sponsors and Collaborators
Orlando Health, Inc.
Abbott
Investigators
Principal Investigator: Jane Boggs, MD Physician
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00356018     History of Changes
Other Study ID Numbers: 3D20-2006
Study First Received: July 21, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Orlando Health, Inc.:
Epilepsy
Compliance

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014