Actively Recruiting
Observational Study of Cenobamate Impact on Healthcare Use in Adults with Uncontrolled Focal-Onset Seizures
Led by Aziende Chimiche Riunite Angelini Francesco S.p.A · Updated on 2025-10-02
200
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating how the drug cenobamate affects healthcare resource use for adults with epilepsy who have uncontrolled focal onset seizures. This observational, retrospective study compares medical resource use before and after patients start cenobamate as an additional therapy because previous anti-seizure medications were not effective or tolerable. Data from medical charts of 200 patients across 10 sites in 5 countries will be collected and analyzed. The study focuses on adult patients who began treatment with cenobamate as adjunctive therapy according to approved guidelines. Patients included have uncontrolled focal seizures despite 2 to 5 prior anti-seizure medications and have at least 6 months of data before starting cenobamate and 12 months of data afterward. This retrospective chart review gathers real-world data without altering patient treatment. Participants medical records will be reviewed for healthcare resource use related to epilepsy, including hospital visits, emergency care, medication use, surgeries, and phone or virtual contacts over a 12-month period before and after starting cenobamate. Researchers will also assess safety data and how concomitant anti-seizure medications change. The study is conducted under data protection regulations and will provide insights into the impact of cenobamate on managing uncontrolled focal seizures.
CONDITIONS
Brief Title
REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
Research Team
L
Lars Nicklasson
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