An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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 design
240 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal