Looks back at adults with hard-to-control focal seizures treated with cenobamate
Reviews records of adults with hard-to-control seizures before and after cenobamate.
Plain-language title generated from the registry record
Registry title: REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
Key facts
- Where
- Freiburg im Breisgau, Hamburg, and Kork, GermanySee the 3 sites
Where in Germany
- Epilepsiezentrums am Neurozentrum des Universitätsklinikum FreiburgFreiburg im Breisgau, GermanyNot yet recruiting
- EpileptologicumHamburg, GermanyNot yet recruiting
- Diakonie Kork, EpilepsiezentrumKork, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Trial code
- NCT06922175
- Record updated
- 2 October 2025
- Original description
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.Read full original descriptionShow less
Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study
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.
Inclusion: Male and female patients of any ethnic origin ≥18 years old at index date; 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; Patients presenting at least 1 seizure a month in the last 6 months prior to index date; Patients with at least 6 months of data coverage in the medical records prior to the index date; Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months); 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: Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date; Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors; Patients with specific syndrome (e.g. LGS and Dravet); Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC; Patients who started cenobamate within an EAP; Pregnancy or lactation; Patients without self-judgement ability; Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine).