Compare Tolerability of an Overnight Switch to Gradual Switch Between Two Different Forms of Depakote

Veterans Affairs Medical Center, Miami

Status and phase

Unknown

Phase 4

Conditions

Behavioral Disturbance

Epilepsy

Treatments

Procedure: Rapid versus slow conversion

Study type

Interventional

Funder types

Other U.S. Federal agency

Industry

Identifiers

NCT00312676

7332.55b

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria