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

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

Plain Language Summary

Simplified for easier understanding

This is a real-world data study reviewing medical records of epilepsy patients who started a newer anti-seizure medication called cenobamate. The goal is to understand how this medication affects healthcare use (like hospital visits) in people whose seizures weren't controlled by previous drugs. **You may be eligible if...** - You are 18 or older - You have epilepsy with focal-onset seizures that were uncontrolled despite trying 2–5 previous anti-seizure medications - You started cenobamate treatment at a defined point in time - You had at least 1 seizure per month in the 6 months before starting cenobamate - Your medical records cover at least 6 months before and 12 months after starting treatment **You may NOT be eligible if...** - You have not had prior inadequate seizure control - Your medical records are incomplete for the required timeframes - You did not give consent for personal data processing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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