Recruiting

Depakote vs. Depakote

Sponsor:

Veterans Affairs Medical Center, Miami

Code:

NCT00312676

Conditions

Epilepsy

Behavioral Disturbance

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Rapid versus slow conversion

Study Details

Brief summary:

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.

Conditions

Epilepsy

Behavioral Disturbance

Study ID

NCT00312676

Start date

Mar, 2006

Status verified date

Mar, 2006

Completion date

Oct, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 60 yo and older on stable dose of valproate (Depakote DR)

Exclusion Criteria:

  • Unstable neurolgical, medical or psychiatric disorder

Study Design

Enrollment

20 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Rapid versus slow conversion

Primary outcome measure

  • Between group comparisons of GI and CNS side effect burden [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Renato Seguro, MD

305-575-7000wallace3299@epiworld.com

Trichia Ramsay

305-575-7000trichia@epiworld.com

Locations

Miami VA Medical Center

Recruiting

Miami, Florida, United States, 33125

Contacts

R. Eugene Ramsay, MD

305-575-3192eramsay@epiworld.com

Principal Investigator:

R. Eugene Ramsay, MD

More Information

Sponsor

Veterans Affairs Medical Center, Miami

Last update posted

Apr 10, 2006

Last verified

Mar, 2006

Keywords

  • Tolerability
  • Depakote DR
  • Depakote ER
  • Elderly
  • Conversion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Veterans Affairs Medical Center, Miami on 2006-04-10.