Clinical trial NCT06922175: REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy With Uncontrolled Focal-onset Seizures
Keywords: anti-seizure medications
Epilepsy
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
Collaborators: name: 1Med
First posted: 2025-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines
timeFrame: 0-12 months
Secondary outcomes:
measure: Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care
timeFrame: 0-12 months
measure: Effectiveness of cenobamate used as adjunctive therapy
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on epilepsy-related surgery
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on comorbidity-related healthcare resources utilization (HCRU)
timeFrame: 0-12 months
measure: Impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions
timeFrame: 0-12 months
measure: Safety of cenobamate used as adjunctive therapy
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Freiburg im Breisgau
country: Germany
facility: Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Epileptologicum
city: Kork
country: Germany
facility: Diakonie Kork, Epilepsiezentrum
city: Heeze
country: Netherlands
facility: Kempenhaeghe - Academisch Centrum voor Epilepsie
city: Barcelona
country: Spain
facility: Epilepsy Unit - Neurology Department Valle de Hebron Hospital
city: Madrid
country: Spain
facility: Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos
city: Valencia
country: Spain
facility: Consorcio Hosp. General Universitario Valencia
city: Zurich
country: Switzerland
facility: Department of Neurology, University Hospital Zurich
city: Glasgow
country: United Kingdom
facility: Institute of Neurosciences NHS Greater Glasgow and Clyde
state: UK
city: Wolverhampton
country: United Kingdom
facility: Epilepsies - The Royal Wolverhampton NHS Trust
state: UK
Study officials:
References: