Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Epilepsy |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 60 - 90 |
| Updated: | 4/2/2016 |
| Start Date: | March 2006 |
| End Date: | October 2006 |
| Contact: | Renato Seguro, MD |
| Email: | wallace3299@epiworld.com |
| Phone: | 305-575-7000 |
Conversion From Multiple-Daily Dose Enteric-Coated Depakote to Once-Daily Depakote ER in Elderly Outpatients With Epilepsy or Behavioral Disturbances:
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.
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.
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.
(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.
Inclusion Criteria:
- 60 yo and older on stable dose of valproate (Depakote DR)
Exclusion Criteria:
- Unstable neurolgical, medical or psychiatric disorder
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