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| Sponsor: | Orlando Health, Inc. |
|---|---|
| Collaborator: |
Abbott |
| Information provided by: | Orlando Health, Inc. |
| ClinicalTrials.gov Identifier: | NCT00356018 |
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 IV |
| Study Type: | Observational |
| Study Design: | Additional Descriptors: Psychosocial Observational Model: Defined Population Time Perspective: Longitudinal 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | March 2007 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Jane Boggs, MD | 407-841-2452 | jane.boggs@orhs.org |
| Contact: Robert G Colern, RN | 321-843-4210 | robert.colern@orhs.org |
| United States, Florida | |
| Orlando Regional Lucerne Hospital | Not yet recruiting |
| Orlando, Florida, United States, 32801 | |
| Principal Investigator: Jane Boggs, MD | |
| Principal Investigator: | Jane Boggs, MD | Physician |
More Information
| ClinicalTrials.gov Identifier: | NCT00356018 History of Changes |
| Other Study ID Numbers: | 3D20-2006 |
| Study First Received: | July 21, 2006 |
| Last Updated: | July 21, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Epilepsy Compliance |
|
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 |
