REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization

Aziende Chimiche Riunite Angelini Francesco S.p.A200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Epilepsy With Uncontrolled Focal-onset Seizures

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female patients of any ethnic origin ≥18 years old at index date; 2. Patients with a diagnosis of epilepsy with uncontrolled focal-onset seizures despite the previous treatment with from 2 to 5 ASMs who started treatment with cenobamate at index date; 3. Patients presenting at least 1 seizure a month in the last 6 months prior to index date; 4. Patients with at least 6 months of data coverage in the medical records prior to the index date; 5. Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months). 6. Patients who give the consent to the processing of personal data according to the General Data Protection Regulation (GDPR) and/or other applicable local regulation. Exclusion Criteria: 1. Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC; 2. Patients who started cenobamate within an EAP; 3. Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors; 4. Patients with specific syndrome (e.g. LGS and Dravet); 5. Pregnancy or lactation; 6. Patients without self-judgement ability; 7. Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine); 8. Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.

Locations (10)

Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany, Germany

NOT_YET_RECRUITING

Epileptologicum

Hamburg, Germany, Germany

NOT_YET_RECRUITING

Diakonie Kork, Epilepsiezentrum

Kork, Germany, Germany

NOT_YET_RECRUITING

Kempenhaeghe - Academisch Centrum voor Epilepsie

Heeze, Netherlands, Netherlands

NOT_YET_RECRUITING

Epilepsy Unit - Neurology Department Valle de Hebron Hospital

Barcelona, Spain, Spain

RECRUITING

Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos

Madrid, Spain, Spain

RECRUITING

Consorcio Hosp. General Universitario Valencia

Valencia, Spain, Spain

RECRUITING

Department of Neurology, University Hospital Zurich

Zurich, Switzerland, Switzerland

RECRUITING

Institute of Neurosciences NHS Greater Glasgow and Clyde

Glasgow, UK, United Kingdom

RECRUITING

Epilepsies - The Royal Wolverhampton NHS Trust

Wolverhampton, UK, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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;

Time frame: 0-12 months

Secondary Outcomes

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

Time frame: 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 dose of co-ASMs

Time frame: 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

Time frame: 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

Time frame: 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;

Time frame: 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);

Time frame: 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: * the number of epilepsy-related surgery (how many patients initiated cenobamate while they were in waiting list or post-surgical intervention, i.e. surgical failure); * the number of hospitalizations due to surgery related to epilepsy (e.g. fractures due to falls); * the number of Intensive Care Unit (ICU) visits;

Time frame: 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: * Number and length of hospitalizations of all-cause inpatient visits, * Number of ER visits, * Number of outpatient visits. All-cause HCRU will be defined as HCRU due to any cause;

Time frame: 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.

Time frame: 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.

Time frame: 0-12 months

REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization

Overview

Conditions

Eligibility

Locations (10)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts