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

NCT06922175 · tracked via the Priya Life Science UK tracker

Sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A

Phase

Observational

Started

2024-12-19

Last updated

2025-10-02

Condition(s) studied

Epilepsy With Uncontrolled Focal-onset Seizures

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines. — 0-12 months
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
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines. — 0-12 months
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
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines — 0-12 months
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
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines — 0-12 months
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;

Trial sites (10)

Facility	City	Region	Status
Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg	Freiburg im Breisgau	Germany	Not Yet Recruiting
Epileptologicum	Hamburg	Germany	Not Yet Recruiting
Diakonie Kork, Epilepsiezentrum	Kork	Germany	Not Yet Recruiting
Kempenhaeghe - Academisch Centrum voor Epilepsie	Heeze	Netherlands	Not Yet Recruiting
Epilepsy Unit - Neurology Department Valle de Hebron Hospital	Barcelona	Spain	Recruiting
Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos	Madrid	Spain	Recruiting
Consorcio Hosp. General Universitario Valencia	Valencia	Spain	Recruiting
Department of Neurology, University Hospital Zurich	Zurich	Switzerland	Recruiting
Institute of Neurosciences NHS Greater Glasgow and Clyde	Glasgow	UK	Recruiting
Epilepsies - The Royal Wolverhampton NHS Trust	Wolverhampton	UK	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06922175 on ClinicalTrials.gov ↗ ← All trials in the UK