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

Launched by AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO S.P.A · Apr 9, 2025

Keywords

ClinConnect Summary

The REACH study is looking at how a medication called cenobamate affects the healthcare needs of adults with epilepsy who have uncontrolled focal-onset seizures. These are seizures that start in one area of the brain and may not respond well to other treatments. The study will compare healthcare resources used by patients before and after they start taking cenobamate. Researchers will gather information from medical records of about 200 patients across five countries.

To be part of this study, participants must be at least 18 years old, have been diagnosed with epilepsy and have tried two to five other epilepsy medications without success. They should have been experiencing at least one seizure per month in the six months before starting cenobamate and must have enough medical record data from both before and after starting the medication. It's important to know that certain conditions, like progressive neurological diseases or substance abuse, may exclude someone from participating. This study is currently recruiting participants, and anyone interested will be asked for their consent to use their medical information in a way that protects their privacy.

Gender

ALL

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.