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| Name | Class |
|---|---|
| 1Med | OTHER |
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The Study is an observational, retrospective study which aim is to assess cenobamate's healthcare resources utilization (HCRU) in the management of uncontrolled focal onset seizures. The amin objective is to compare the resource utilization before and after the use of cenobamate. Data from medical charts will be used and inserted into the eCRF from which the analyses will be conducted. Data from 200 patients from 10 sites in 5 countries are included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients affected by epilepsy with focal-onset seizures | Adult patients affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more ASMs (anti-seizure medications), due to efficacy or tolerability issues, who start a treatment with cenobamate as an adjunctive therapy (according to SmPC), in real world setting, and have at least 6 months of data on treatment and HCRU (if any) prior to cenobamate starting date. |
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| Measure | Description | Time Frame |
|---|---|---|
| Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines. | To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU, will be collected the number of epilepsy/epilepsy treatment-related hospitalizations during all the observation period | 0-12 months |
| Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines. | To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU,will be collected the length of epilepsy/epilepsy treatment-related hospitalizations during all the observation period | 0-12 months |
| Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines | To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU will be collected the number of epilepsy/epilepsy treatment-related outpatient visits (OP) during all the observation period | 0-12 months |
| Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines | To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU will be collected the number of epilepsy/epilepsy treatment-related emergency room (ER) visits; | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) | To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Switch/add-on of other ASMs | 0-12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more anti-seizure medications (ASMs), due to efficacy or tolerability issues, who start a treatment with cenobamate as an adjunctive therapy (according to SmPC), in real world setting, and have at least 6 months of data on treatment and healthcare resources utilization (HCRU) (if any) prior to cenobamate starting date.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Nicklasson | Contact | +46 702528077 | Lars.nicklasson@angelinipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg | Not yet recruiting | Freiburg im Breisgau | Germany | Germany |
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| Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) |
To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Changes in the dose of co-ASMs |
| 0-12 months |
| Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) | To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Changes in the number of co-ASMs | 0-12 months |
| Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs) | To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Time to discontinuation of ASMs | 0-12 months |
| Impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care | To evaluate the impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care, the number of epilepsy/epilepsy treatment related emergency care, ambulance use, the number of outpatient visits with neurologists, and the number of epilepsy specialist nurses' intervention will be collected; | 0-12 months |
| Effectiveness of cenobamate used as adjunctive therapy | To evaluate the effectiveness of cenobamate used as adjunctive therapy, seizure frequency at baseline and at routinely scheduled follow-up visits, till the end of observation will be collected. For comparability, seizure frequency will be extrapolated per month (28 days); | 0-12 months |
| Impact of cenobamate used as adjunctive therapy on epilepsy-related surgery | To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related surgery the following data will be collected:
| 0-12 months |
| Impact of cenobamate used as adjunctive therapy on comorbidity-related healthcare resources utilization (HCRU) | To evaluate the impact of cenobamate used as adjunctive therapy on comorbidity-related HCRU, the following data will be collected:
| 0-12 months |
| Impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions | To evaluate the impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions, the number of phone calls/virtual interventions will be collected. | 0-12 months |
| Safety of cenobamate used as adjunctive therapy | To evaluate safety of cenobamate used as adjunctive therapy, the number, type and severity of, adverse events, adverse drug reactions will be collected. Moreover, changes in the number, type, dose of concomitant medications other than anti-seizure medications will be collected over the duration of the study. | 0-12 months |
| Epileptologicum | Not yet recruiting | Hamburg | Germany | Germany |
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| Diakonie Kork, Epilepsiezentrum | Not yet recruiting | Kork | Germany | Germany |
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| Kempenhaeghe - Academisch Centrum voor Epilepsie | Not yet recruiting | Heeze | Netherlands | Netherlands |
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| Epilepsy Unit - Neurology Department Valle de Hebron Hospital | Recruiting | Barcelona | Spain | Spain |
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| Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos | Recruiting | Madrid | Spain | Spain |
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| Consorcio Hosp. General Universitario Valencia | Recruiting | Valencia | Spain | Spain |
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| Department of Neurology, University Hospital Zurich | Recruiting | Zurich | Switzerland | Switzerland |
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| Institute of Neurosciences NHS Greater Glasgow and Clyde | Recruiting | Glasgow | UK | United Kingdom |
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| Epilepsies - The Royal Wolverhampton NHS Trust | Recruiting | Wolverhampton | UK | United Kingdom |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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