NCT00356018

Brief Summary

To determine, in a randomized, parallel open-label fashion, compliance rates between once-daily extended-release divalproex sodium tablets (Depakote-ER®, Abbott Labs) versus multiple-daily dose valproic acid capsules (Depakene®, Abbott Labs) in an epilepsy population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

First QC Date

July 21, 2006

Last Update Submit

March 3, 2020

Conditions

Epilepsy

Keywords

EpilepsyCompliance

Interventions

ComplianceBEHAVIORAL

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population includes both patients whose seizures are relatively well controlled on their present conventional, enteric-coated twice-daily or three-times daily Divalproex sodium regimen.

You may qualify if:

  • \) Patients must demonstrate a 75% or greater compliance rate with DR via calendar during the week of familiarity with the MEMs unit. The threshold value of 75% has been chosen since research shows that people take approximately 75% of their AED(s) as prescribed (13,14), and the same numerical value is frequently used in determining whether or not to retain a patient in clinical Phase 2a-3b industry-sponsored study.

You may not qualify if:

  • \) Patients unwilling or unable to utilize the MEMs monitoring unit; 6) Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Regional Lucerne Hospital

Orlando, Florida, 32801, United States

Location

MeSH Terms

Conditions

EpilepsyPatient Compliance

Interventions

Compliance

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

ElasticityMechanical PhenomenaPhysical Phenomena

Study Officials

  • Jane Boggs, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2006

First Posted

July 25, 2006

Study Start

July 1, 2006

Study Completion

May 1, 2007

Last Updated

March 4, 2020

Record last verified: 2020-03

Locations

US(1)