169(A)AV23432
Research type
Research Study
Full title
REACH: Retrospective evaluation of cenobamate’s health care resource utilization (HCRU) in the management of uncontrolled focal onset seizures – A retrospective, chart review study
IRAS ID
347798
Contact name
Giorgia Bigioni
Contact email
+41 (0)76 245 42 75
Sponsor organisation
ANGELINI S.p.A.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 5 days
Research summary
Epilepsies are among the most common chronic disorders of the brain. Focal onset seizures (FOS) are the most prevalent type of seizures and can pose a significant risk to individual health and impair quality of life. The management of epilepsy is mainly symptomatic, aimed at reducing the risk of seizure recurrence; anti-seizure medications (ASMs) are the mainstay of treatment. More than 50% of patients do not achieve seizure freedom with initial monotherapy, and treatment options for these patients include other ASM monotherapies or combination therapy using additional ASMs as adjunctive therapy. Cenobamate is a 3rd gen ASM available to treat adults with focal seizures. In Europe, cenobamate is indicated as an adjunctive treatment Cenobamate mechanism of action act by preventing seizure initiation and potentially limiting the spread of seizure. The aim of this study is to assess cenobamate’s healthcare resources utilization (HCRU) in the management of uncontrolled focal onset seizures. 200 adult patients affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more ASMs who start a treatment with cenobamate as an adjunctive therapy will be involved in this study that aims to assess cenobamate’s healthcare resources utilization (HCRU) in the management of uncontrolled focal onset seizures. This observationa, retrospective study will be done in 5 contries: Spain, Germany, UK, Netherlands, Switzerland. Only data recorded in medical chart will be collected.
REC name
HSC REC A
REC reference
24/NI/0147
Date of REC Opinion
19 Dec 2024
REC opinion
Further Information Favourable Opinion