Evaluating the impact of cenobamate on healthcare resource use in epilepsy patients

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

This study looks at how using cenobamate affects the healthcare needs of people with uncontrolled focal-onset seizures.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A (Industry-sponsored)
• Locations: 10 sites (Freiburg im Breisgau, Germany and 9 other locations)
• Trial ID: NCT06922175 on ClinicalTrials.gov

What this trial studies

This observational, retrospective study aims to assess the healthcare resource utilization (HCRU) associated with cenobamate in patients suffering from uncontrolled focal-onset seizures. The study will compare resource utilization before and after the initiation of cenobamate treatment, utilizing data extracted from medical charts. A total of 200 patients from 10 sites across 5 countries will be included in the analysis, providing insights into the effectiveness of cenobamate in managing epilepsy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with uncontrolled focal-onset seizures who have tried multiple anti-seizure medications without success.

Not a fit: Patients who have contraindications to adjunctive anti-seizure medications or those who started cenobamate under an expanded access program may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on how cenobamate affects healthcare resource use, potentially leading to improved management strategies for epilepsy patients.

How similar studies have performed: While this study utilizes a retrospective observational approach, similar studies evaluating the impact of anti-seizure medications on healthcare resource utilization have shown promising results.

Eligibility criteria

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.

Where this trial is running

Freiburg im Breisgau, Germany and 9 other locations

• 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)

Study contacts

• Study coordinator: Lars Nicklasson

Conditions Epilepsy With Uncontrolled Focal-onset Seizures; anti-seizure medications; Epilepsy