Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The hypothesis is that the characteristics of extended release Depakote will allow overnight conversion of immediate release to extended release form of Depakote. This has been tested successfully in younger patients but not in individuals over the age of 60. We will include individuals between 60 and 80 years old.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy Behavioral Disturbance |
Procedure: Rapid versus slow conversion |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances: |
- Between group comparisons of GI and CNS side effect burden
- Between group comparison of Quality of Life as measured bye the QOLIE-89
- Between group comparison of trough Total and Free valproic acid serum levels
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | October 2006 |
Twenty patients will be randomily assigned to convert overnight (10 pts) or over six days (10 pts). Side effects will be formally evaluated by the UKU side effect rating scal which will be done 7 days before conversion (day -7), the day of conversion (day 0)and then at the start of days +2, +7 and +14. This investigator conducting the evaluation will be blinded to the conversion status of the patient. Secondary measures to be obtained will be a Quality of Life measure (QOLIE-89) on Day 0 and +14. Plasma samples will be obtained on Day 0 and +14 before dosing for total and free valproic blood level.
Eligibility| Ages Eligible for Study: | 60 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 60 yo and older on stable dose of valproate (Depakote DR)
Exclusion Criteria:
- Unstable neurolgical, medical or psychiatric disorder
Contacts and Locations| Contact: Renato Seguro, MD | 305-575-7000 ext 6033 | wallace3299@epiworld.com |
| Contact: Trichia Ramsay | 305-575-7000 ext 3963 | trichia@epiworld.com |
| United States, Florida | |
| Miami VA Medical Center | Recruiting |
| Miami, Florida, United States, 33125 | |
| Contact: R. Eugene Ramsay, MD 305-575-3192 eramsay@epiworld.com | |
| Principal Investigator: R. Eugene Ramsay, MD | |
| Principal Investigator: | R. Eugene Ramsay, MD | Miami Veterans Administration Medical Center |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00312676 History of Changes |
| Other Study ID Numbers: | 7332.55b |
| Study First Received: | April 6, 2006 |
| Last Updated: | April 6, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by Veterans Affairs Medical Center, Miami:
|
Tolerability Depakote DR Depakote ER Elderly Conversion |
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 May 19, 2013