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

ConditionEpilepsy With Uncontrolled Focal-onset Seizures
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

This trial does not accept healthy volunteers

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 population

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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Adult patients affected by epilepsy with focal-onset seizures

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aziende Chimiche Riunite Angelini Francesco S.p.A

Lead sponsor

1Med

Collaborator

Source ClinicalTrials.gov
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