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

Recruiting now

Conditions studied: Epilepsy With Uncontrolled Focal-onset Seizures

In brief

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.

Key facts

Study ID

NCT06922175

Run by

Aziende Chimiche Riunite Angelini Francesco S.p.A

People needed

200

Starts

2024-12-19

Expected to finish

2025-12-30

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Epilepsies - The Royal Wolverhampton NHS Trust — Wolverhampton, UK, United Kingdom (enrolling)
• Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos — Madrid, Spain, Spain (enrolling)
• Consorcio Hosp. General Universitario Valencia — Valencia, Spain, Spain (enrolling)
• Department of Neurology, University Hospital Zurich — Zurich, Switzerland, Switzerland (enrolling)
• Institute of Neurosciences NHS Greater Glasgow and Clyde — Glasgow, UK, United Kingdom (enrolling)
• Epilepsy Unit - Neurology Department Valle de Hebron Hospital — Barcelona, Spain, Spain (enrolling)
• Epileptologicum — Hamburg, Germany, Germany
• Diakonie Kork, Epilepsiezentrum — Kork, Germany, Germany
• Kempenhaeghe - Academisch Centrum voor Epilepsie — Heeze, Netherlands, Netherlands
• Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany, Germany

Full record on ClinicalTrials.gov

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