Evaluating the impact of cenobamate on healthcare resource use in epilepsy patients
Official title: Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study
Run by Aziende Chimiche Riunite Angelini Francesco S.p.A · NCT06922175 · Data updated 2026-11-12
This study looks at how using cenobamate affects the healthcare needs of people with uncontrolled focal-onset seizures.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Aziende Chimiche Riunite Angelini Francesco S.p.A Industry-sponsored |
| Locations | 10 sites (Freiburg im Breisgau, Germany and 9 other locations) |
| Status | Recruiting |
| Started | December 19, 2024 |
| Main results expected | December 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT06922175 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
Show 4 more locations
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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
Study contacts
- Study coordinator: Lars Nicklasson
- Email: Lars.nicklasson@angelinipharma.com
- Phone: +46 702528077
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.