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

NCT01332539 | Completed

• 1 other identifier: 114872
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epilepsy, Partial

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

• 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.

• 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

Study Arms (2)

drug-resistant partial epilepsy

Other: no intervention

controlled partial epilepsy

Other: no intervention

Interventions

no intervention OTHER

non-interventional study

Also known as: non-interventional study

controlled partial epilepsy; drug-resistant partial epilepsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatient with partial epilepsy

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 11, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 27, 2013

Record last verified: 2013-04