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

Epilepsy, Partial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332539
• Other study ID #: 114872
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: May 23, 2013
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: April 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA - Italian Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Partial

Intervention

Other:
• no intervention
non-interventional study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total cost (direct and indirect) per patient per year of drug-resistant partial patients collected in the retrospective and in the prospective phase		9 months: a 3-month retrospective and a 6-month prospective.	No
Secondary	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.		9 months. a 3-month retrospective and a 6-month prospective.	No
Secondary	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)		9 months: a 3-month retrospective and a 6-month prospective.	No
Secondary	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		questionnaire administerd at visit 1 only	No