Naturalistic Study to Evaluate the Utilization of Care Se... | NCT00522522

Studies
Naturalistic Study to Evaluate the Utilization of Care Services Associated to the Diagnostic Process of Any Kind of Epilepsy

NCT00522522

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

May 30, 2012Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Epilepsy

Interventions

Not provided

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

ID	Type	Description	Link
EPILIVE

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Aug 27, 2007

First Submission Date that Met QC Criteria

Aug 27, 2007

First Posted Date

Aug 29, 2007Estimated

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

May 29, 2012

Last Update Posted Date

May 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Naturalistic, multicentre, epidemiological study to evaluate the care services used during the process of diagnosis of any kind of epilepsy. Data about services since first seizure until confirmed diagnosis will be examined.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients of both sexes 16 years old or older, being diagnosed of any kind of EPILEPSY (criteria ILAE) and with diagnosis being confirmed by a Neurologist over the last 6 months and with write informed consent.

Exclusion Criteria:

Patients with epilepsy diagnosis confirmed by a Neurologist over the last 6 months before the study or with incapacity to fulfill the requirements of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients being diagnosed of any kind of EPILEPSY (criteria ILAE 2005) and with diagnosis being confirmed by a Neurologist over the last 6 months.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCB Pharma		Smyrna	Georgia		United States

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy
D004194	Disease

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided