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

NCT ID: NCT00312676

Last Updated: 2006-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Epilepsy Behavioral Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rapid versus slow conversion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unstable neurolgical, medical or psychiatric disorder
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

Veterans Affairs Medical Center, Miami

FED

Sponsor Role lead

Principal Investigators

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R. Eugene Ramsay, MD

Role: PRINCIPAL_INVESTIGATOR

Miami Veterans Administration Medical Center

Locations

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Miami VA Medical Center

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Renato Seguro, MD

Role: CONTACT

[email protected]
305-575-7000 ext. 6033

Trichia Ramsay

Role: CONTACT

[email protected]
305-575-7000 ext. 3963

Facility Contacts

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R. Eugene Ramsay, MD

Role: primary

[email protected]
305-575-3192

Other Identifiers

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7332.55b

Identifier Type: -

Identifier Source: org_study_id