REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utili
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 a
| Condition(s) | Epilepsy With Uncontrolled Focal-onset Seizures |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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. |
| Who can participate | 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: |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Aziende Chimiche Riunite Angelini Francesco S.p.A |
| Locations | Freiburg im Breisgau, Germany, Germany; Hamburg, Germany, Germany; Kork, Germany, Germany; Heeze, Netherlands, Netherlands; Barcelona, Spain, Spain; Madrid, Spain, Spain (+4 more sites) |
| Start date | 2024-12-19 |
| NCT ID | NCT06922175 |
| Official listing | https://clinicaltrials.gov/study/NCT06922175 |