RecruitingNCT06922175

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

Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study

Sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A

Enrollment

200 participants

Start Date

Dec 19, 2024

Study Type

OBSERVATIONAL

Conditions

Epilepsy With Uncontrolled Focal-onset Seizures

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria8

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.

Locations(10)

Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany, Germany

Epileptologicum

Hamburg, Germany, Germany

Diakonie Kork, Epilepsiezentrum

Kork, Germany, Germany

Kempenhaeghe - Academisch Centrum voor Epilepsie

Heeze, Netherlands, Netherlands

Epilepsy Unit - Neurology Department Valle de Hebron Hospital

Barcelona, Spain, Spain

Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos

Madrid, Spain, Spain

Consorcio Hosp. General Universitario Valencia

Valencia, Spain, Spain

Department of Neurology, University Hospital Zurich

Zurich, Switzerland, Switzerland

Institute of Neurosciences NHS Greater Glasgow and Clyde

Glasgow, UK, United Kingdom

Epilepsies - The Royal Wolverhampton NHS Trust

Wolverhampton, UK, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06922175