Clinical trial NCT01332539: An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
Official title: An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy, Partial
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient with partial epilepsy

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: total cost (direct and indirect) per patient per year of drug-resistant partial patients collected in the retrospective and in the prospective phase
timeFrame: 9 months: a 3-month retrospective and a 6-month prospective.
Secondary outcomes:
measure: 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.
timeFrame: 9 months. a 3-month retrospective and a 6-month prospective.
measure: 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)
timeFrame: 9 months: a 3-month retrospective and a 6-month prospective.
measure: 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
timeFrame: questionnaire administerd at visit 1 only
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: