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

Recruitingn/aAges 18 Years - anyAllAziende Chimiche Riunite Angelini Francesco S.p.A
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

10 sites
Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Epileptologicum
Hamburg, Germany
Diakonie Kork, Epilepsiezentrum
Kork, Germany
Kempenhaeghe - Academisch Centrum voor Epilepsie
Heeze, Netherlands
Epilepsy Unit - Neurology Department Valle de Hebron Hospital
Barcelona, Spain
Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos
Madrid, Spain
Consorcio Hosp. General Universitario Valencia
Valencia, Spain
Department of Neurology, University Hospital Zurich
Zurich, Switzerland

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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