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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332539
First received: April 7, 2011
Last updated: May 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Epilepsy, Partial
Other: no intervention

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
drug-resistant partial epilepsy Other: no intervention
non-interventional study
Other Name: non-interventional study
controlled partial epilepsy Other: no intervention
non-interventional study
Other Name: non-interventional study

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatient with partial epilepsy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332539

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01332539     History of Changes
Other Study ID Numbers: 114872
Study First Received: April 7, 2011
Last Updated: May 23, 2013
Health Authority: Italy: AIFA - Italian Ministry of Health

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014