Clinical Trials in Spain / NCT06922175
Recruiting
Observational
REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
NCT06922175 · tracked via the Priya Life Science Spain tracker
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
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 Spain