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

NCT06922175 | Recruiting

• 1 other identifier: 169(A)AV23432
• Study Type: observational
• Target: 200
• Locations: 5 countries
• Sites: 10

Brief 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.

Conditions

Epilepsy With Uncontrolled Focal-onset Seizures

Keywords

anti-seizure medications; Epilepsy

Outcome Measures

Primary Outcomes (4)

• Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.

  To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU, will be collected the number of epilepsy/epilepsy treatment-related hospitalizations during all the observation period

  0-12 months

• Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.

  To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU,will be collected the length of epilepsy/epilepsy treatment-related hospitalizations during all the observation period

  0-12 months

• Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines

  To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU will be collected the number of epilepsy/epilepsy treatment-related outpatient visits (OP) during all the observation period

  0-12 months

• Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines

  To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU will be collected the number of epilepsy/epilepsy treatment-related emergency room (ER) visits;

  0-12 months

Secondary Outcomes (10)

• Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)

  0-12 months

• Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)

  0-12 months

• Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)

  0-12 months

• Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)

  0-12 months

• Impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care

  0-12 months

Study Arms (1)

Adult patients affected by epilepsy with focal-onset seizures

Adult patients affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more ASMs (anti-seizure medications), due to efficacy or tolerability issues, who start a treatment with cenobamate as an adjunctive therapy (according to SmPC), in real world setting, and have at least 6 months of data on treatment and HCRU (if any) prior to cenobamate starting date.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more anti-seizure medications (ASMs), due to efficacy or tolerability issues, who start a treatment with cenobamate as an adjunctive therapy (according to SmPC), in real world setting, and have at least 6 months of data on treatment and healthcare resources utilization (HCRU) (if any) prior to cenobamate starting date.

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.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• 1Med: collaborator

Study Sites (10)

Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany, Germany

NOT YET RECRUITING

Epileptologicum

Hamburg, Germany, Germany

NOT YET RECRUITING

Diakonie Kork, Epilepsiezentrum

Kork, Germany, Germany

NOT YET RECRUITING

Kempenhaeghe - Academisch Centrum voor Epilepsie

Heeze, Netherlands, Netherlands

NOT YET RECRUITING

Epilepsy Unit - Neurology Department Valle de Hebron Hospital

Barcelona, Spain, Spain

RECRUITING

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

Madrid, Spain, Spain

RECRUITING

Consorcio Hosp. General Universitario Valencia

Valencia, Spain, Spain

RECRUITING

Department of Neurology, University Hospital Zurich

Zurich, Switzerland, Switzerland

RECRUITING

Institute of Neurosciences NHS Greater Glasgow and Clyde

Glasgow, UK, United Kingdom

RECRUITING

Epilepsies - The Royal Wolverhampton NHS Trust

Wolverhampton, UK, United Kingdom

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Lars Nicklasson

CONTACT

+46 702528077; Lars.nicklasson@angelinipharma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 10, 2025
• Study Start: December 19, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

CH (1); GB (2); DE (3); NL (1); ES (3)