Compare Tolerability of an Overnight Switch to Gradual Sw... | NCT00312676

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

NCT00312676

Sponsor

Veterans Affairs Medical Center, Miami

Status

Unknown status

Last Update Posted

Apr 10, 2006Estimated

Enrollment

Phase

Phase 4

Conditions

Epilepsy
Behavioral Disturbance

Interventions

Rapid versus slow conversion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Oct 2006

First Submitted Date

Apr 6, 2006

First Submission Date that Met QC Criteria

Apr 6, 2006

First Posted Date

Apr 10, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2006

Last Update Posted Date

Apr 10, 2006Estimated

Name	Class
Abbott	INDUSTRY

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Rapid versus slow conversion	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Between group comparisons of GI and CNS side effect burden

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unstable neurolgical, medical or psychiatric disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Renato Seguro, MD	Contact	305-575-7000	6033	wallace3299@epiworld.com
Trichia Ramsay	Contact	305-575-7000	3963	trichia@epiworld.com

Overall Officials

Name	Affiliation	Role
R. Eugene Ramsay, MD	Miami Veterans Administration Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Miami VA Medical Center	Recruiting	Miami	Florida	33125	United States

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D001523	Mental Disorders

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided