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

Last updated: April 9, 2025
Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Overall Status: Active - Recruiting

Phase

N/A

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT06922175
169(A)AV23432
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 despitethe previous treatment with from 2 to 5 ASMs who started treatment with cenobamateat index date;

  3. Patients presenting at least 1 seizure a month in the last 6 months prior to indexdate;

  4. Patients with at least 6 months of data coverage in the medical records prior to theindex 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 theGeneral Data Protection Regulation (GDPR) and/or other applicable local regulation.

Exclusion

Exclusion Criteria:

  1. Patients who meet any of the contraindications to the administration of adjunctiveASMs according to their approved SmPC;

  2. Patients who started cenobamate within an EAP;

  3. Progressive neurological disease, including degenerative CNS diseases and/orprogressive 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 andnicotine);

  8. Patients participating in any pharmacological or nonpharmacological interventionalstudy starting from 6 months before the index date.

Study Design

Total Participants: 200
Study Start date:
December 19, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg

    Freiburg im Breisgau,
    Germany

    Site Not Available

  • Epileptologicum

    Hamburg,
    Germany

    Site Not Available

  • Diakonie Kork, Epilepsiezentrum

    Kork,
    Germany

    Site Not Available

  • Kempenhaeghe - Academisch Centrum voor Epilepsie

    Heeze,
    Netherlands

    Site Not Available

  • Epilepsy Unit - Neurology Department Valle de Hebron Hospital

    Barcelona,
    Spain

    Active - Recruiting

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

    Madrid,
    Spain

    Active - Recruiting

  • Consorcio Hosp. General Universitario Valencia

    Valencia,
    Spain

    Active - Recruiting

  • Department of Neurology, University Hospital Zurich

    Zurich,
    Switzerland

    Active - Recruiting

  • Institute of Neurosciences NHS Greater Glasgow and Clyde

    Glasgow, UK
    United Kingdom

    Active - Recruiting

  • Epilepsies - The Royal Wolverhampton NHS Trust

    Wolverhampton, UK
    United Kingdom

    Active - Recruiting

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