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NCT Number: NCT01332539

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

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.

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Key information

Conditions

Epilepsy, Partial Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

non-interventional study

Other names: non-interventional study

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

    Time frame: 9 months: a 3-month retrospective and a 6-month prospective.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2011
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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