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

NCT ID: NCT01332539

Last Updated: 2013-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-11-30

Brief Summary

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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

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

Conditions

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Epilepsy, Partial

Study Design

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Observational Model Type

COHORT

Study Groups

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drug-resistant partial epilepsy

no intervention

Intervention Type OTHER

non-interventional study

controlled partial epilepsy

no intervention

Intervention Type OTHER

non-interventional study

Interventions

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no intervention

non-interventional study

Intervention Type OTHER

Other Intervention Names

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non-interventional study

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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114872

Identifier Type: -

Identifier Source: org_study_id

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