Compliance With Once-Daily Divalproex Extended-Release Tablets (Depakote-ER) Versus Multiple-Daily Dose Valproic Acid Capsules (Depakene) in Epilepsy:
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 |
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.
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.
-
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.
-
Contacts and Locations| United States, Florida | |
| Orlando Regional Lucerne Hospital | |
| Orlando, Florida, United States, 32801 | |
| 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 Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 17, 2013