An observational study in Epilepsy With Uncontrolled Focal-onset Seizures, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Recruiting at 10 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Observational
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's planned enrollment of 200 is above the median of 112 across 540 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more anti-seizure medications (ASMs), 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 healthcare resources utilization (HCRU) (if any) prior to cenobamate starting date.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.
To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU, will be collected the number of epilepsy/epilepsy treatment-related hospitalizations during all the observation period
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.
To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU,will be collected the length of epilepsy/epilepsy treatment-related hospitalizations during all the observation period
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines
To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU will be collected the number of epilepsy/epilepsy treatment-related outpatient visits (OP) during all the observation period
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines
To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related HCRU will be collected the number of epilepsy/epilepsy treatment-related emergency room (ER) visits;
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Switch/add-on of other ASMs
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Changes in the dose of co-ASMs
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Changes in the number of co-ASMs
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
To assess the impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs), the following data will be recorded: Time to discontinuation of ASMs
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care
To evaluate the impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care, the number of epilepsy/epilepsy treatment related emergency care, ambulance use, the number of outpatient visits with neurologists, and the number of epilepsy specialist nurses' intervention will be collected;
Time frame: 0-12 months
Effectiveness of cenobamate used as adjunctive therapy
To evaluate the effectiveness of cenobamate used as adjunctive therapy, seizure frequency at baseline and at routinely scheduled follow-up visits, till the end of observation will be collected. For comparability, seizure frequency will be extrapolated per month (28 days);
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related surgery
To assess the impact of cenobamate used as adjunctive therapy on epilepsy-related surgery the following data will be collected: * the number of epilepsy-related surgery (how many patients initiated cenobamate while they were in waiting list or post-surgical intervention, i.e. surgical failure); * the number of hospitalizations due to surgery related to epilepsy (e.g. fractures due to falls); * the number of Intensive Care Unit (ICU) visits;
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on comorbidity-related healthcare resources utilization (HCRU)
To evaluate the impact of cenobamate used as adjunctive therapy on comorbidity-related HCRU, the following data will be collected: * Number and length of hospitalizations of all-cause inpatient visits, * Number of ER visits, * Number of outpatient visits. All-cause HCRU will be defined as HCRU due to any cause;
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions
To evaluate the impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions, the number of phone calls/virtual interventions will be collected.
Time frame: 0-12 months
Safety of cenobamate used as adjunctive therapy
To evaluate safety of cenobamate used as adjunctive therapy, the number, type and severity of, adverse events, adverse drug reactions will be collected. Moreover, changes in the number, type, dose of concomitant medications other than anti-seizure medications will be collected over the duration of the study.
Time frame: 0-12 months
Started Dec 2024 (actual). Primary completion is estimated for Dec 2025, 12 months after the start.
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