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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.
observational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug-resistant partial epilepsy |
| ||
| controlled partial epilepsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| total cost (direct and indirect) per patient per year of drug-resistant partial patients collected in the retrospective and in the prospective phase | 9 months: a 3-month retrospective and a 6-month prospective. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
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:
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Outpatient with partial epilepsy
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 | questionnaire administerd at visit 1 only |