Status:
RECRUITING
REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
Lead Sponsor:
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborating Sponsors:
1Med
Conditions:
Epilepsy With Uncontrolled Focal-onset Seizures
Eligibility:
All Genders
18+ years
Brief 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 objectiv...
Eligibility Criteria
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 who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC;
- Patients who started cenobamate within an EAP;
- Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors;
- Patients with specific syndrome (e.g. LGS and Dravet);
- Pregnancy or lactation;
- Patients without self-judgement ability;
- Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine);
- Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.
Key Trial Info
Start Date :
December 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06922175
Start Date
December 19 2024
End Date
December 30 2025
Last Update
October 2 2025
Active Locations (10)
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1
Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, Germany
2
Epileptologicum
Hamburg, Germany, Germany
3
Diakonie Kork, Epilepsiezentrum
Kork, Germany, Germany
4
Kempenhaeghe - Academisch Centrum voor Epilepsie
Heeze, Netherlands, Netherlands