An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy

May 23, 2013 updated by: GlaxoSmithKline
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective. As control group, 120 patients with controlled partial epilepsy will be enrolled. The objective of the study is to describe the burden of illness in this epileptic population both in terms of costs and of quality of life. Costs and quality of life will be also compared between the two populations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective.

Study Type

Observational

Enrollment (Actual)

240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Outpatient with partial epilepsy

Description

Inclusion Criteria:

  • Outpatients
  • Diagnosis of partial epilepsy, defined as active, drug-resistant in accordance to the 2010 ILAE (International League Against Epilepsy) definition and actually taking an add-on therapeutic regimen.
  • Able and willing to give the written informed consent (to be obtained before any study assessment)

For each drug-resistant patient, will be enrolled a patient with the same diagnosis and actually taking an add-on therapy but with controlled epilepsy according to the 2010 ILAE definition.

Exclusion Criteria:

  • Patient currently included in a clinical trial for an AED (Anti-Epileptic Drug)
  • Hospital record data on epilepsy not available in the Investigator's files
  • Patient unable to fill in self-questionnaires (quality of life instrument)
  • Patient currently hospitalized
  • Patient who, according to the Investigator's judgment, is not able to follow the study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
drug-resistant partial epilepsy
Other: no intervention
non-interventional study
Other Names:
  • non-interventional study
controlled partial epilepsy
Other: no intervention
non-interventional study
Other Names:
  • non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total cost (direct and indirect) per patient per year of drug-resistant partial patients collected in the retrospective and in the prospective phase
Time Frame: 9 months: a 3-month retrospective and a 6-month prospective.
9 months: a 3-month retrospective and a 6-month prospective.

Secondary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint is the total cost (direct and indirect) per patient per year of controlled patients collected in the retrospective and in the prospective phase.
Time Frame: 9 months. a 3-month retrospective and a 6-month prospective.
9 months. a 3-month retrospective and a 6-month prospective.
the difference between the group of drug-resistant patients and the control group as regards each single resource consumptions and the direct and indirect costs (single and total)
Time Frame: 9 months: a 3-month retrospective and a 6-month prospective.
9 months: a 3-month retrospective and a 6-month prospective.
The comparison of the seven multi-item scores and the overall score of QOLIE-31 (Quality of life in Epilepsy -31 items) questionnaire between the two patients groups
Time Frame: questionnaire administerd at visit 1 only
questionnaire administerd at visit 1 only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 7, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

May 27, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114872

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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