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

Angelini Pharma

Status: Enrolling

Conditions: Epilepsy With Uncontrolled Focal-onset Seizures

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06922175

169(A)AV23432

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Adult patients affected by epilepsy with focal-onset seizures

Description:

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.