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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed 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.
Sponsor: GlaxoSmithKline

Current Primary Outcome: 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. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]
  • 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. ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: April 7, 2011
Date Started: May 2011
Date Completion:
Last Updated: May 23, 2013
Last Verified: April 2013