Last updated: 11/03/2018 17:21:47

An observational study to assess the burden of drug-resistant partial epilepsy in Italy

GSK study ID
114872
See study documents
Clinicaltrials.gov ID
NCT01332539
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An observational study to assess the burden of drug-resistant partial epilepsy in Italy
Trial 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. 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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:

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.

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.

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

Interventions:
  • Other: no intervention
    • Enrollment:
    240
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy, Partial
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    May 2011 to November 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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.
    • 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
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-30-11

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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