REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAziende Chimiche Riunite Angelini Francesco S.p.A
About this trial
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
Qualifiers
Male and female patients of any ethnic origin ≥18 years old at index date;
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;
Patients presenting at least 1 seizure a month in the last 6 months prior to index date;
Patients with at least 6 months of data coverage in the medical records prior to the index date;
Disqualifiers
Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC;
Patients who started cenobamate within an EAP;
Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors;
Patients with specific syndrome (e.g. LGS and Dravet);
Trial design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 1 trial groupSponsors and collaborators
Aziende Chimiche Riunite Angelini Francesco S.p.A
Lead sponsor
1Med
Collaborator
Source ClinicalTrials.gov