Epilepsy With Uncontrolled Focal-onset SeizuresNCT06922175
REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
An observational study of Epilepsy With Uncontrolled Focal-onset Seizures, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 10 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy With Uncontrolled Focal-onset Seizures
- How many people
- 200 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 19 Dec 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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;
- Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months).
- Patients who give the consent to the processing of personal data according to the General Data Protection Regulation (GDPR) and/or other applicable local regulation.
Who cannot join
- 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);
- Pregnancy or lactation;
- Patients without self-judgement ability;
- Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine);
- Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.
Trial locations and contacts
10 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 5 countries
Germany3 sites, 3 recruiting
- Not yet recruiting
Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Andreas Schulze-Bonhage
- Not yet recruiting
Epileptologicum
Hamburg, Germany
Patrick House
- Not yet recruiting
Diakonie Kork, Epilepsiezentrum
Kork, Germany
Bernhard Steinhoff
Spain3 sites, 3 recruiting
- Recruiting
Epilepsy Unit - Neurology Department Valle de Hebron Hospital
Barcelona, Spain
Manuel Toledo Argany
- Recruiting
Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos
Madrid, Spain
Irene Garcia Morales
- Recruiting
Consorcio Hosp. General Universitario Valencia
Valencia, Spain
Ascensión Castillo Ruiz
United Kingdom2 sites, 2 recruiting
- Recruiting
Institute of Neurosciences NHS Greater Glasgow and Clyde
Glasgow, UK
Craig Heath
- Recruiting
Epilepsies - The Royal Wolverhampton NHS Trust
Wolverhampton, UK
Phil Tittensor
Netherlands1 site, 1 recruiting
- Not yet recruiting
Kempenhaeghe - Academisch Centrum voor Epilepsie
Heeze, Netherlands
H.J.M. Marian Majoie
Switzerland1 site, 1 recruiting
- Recruiting
Department of Neurology, University Hospital Zurich
Zurich, Switzerland
Marian Galovic
About this study
Official title: Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study
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.
- Keywords
- anti-seizure medications, Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients affected by epilepsy with focal-onset seizures | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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;
Measured: 0-12 months
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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;
Measured: 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);
Measured: 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;
Measured: 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;
Measured: 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.
Measured: 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.
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start19 Dec 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy With Uncontrolled Focal-onset SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 1Med
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922175
- Sponsor's protocol ID
- 169(A)AV23432
- Status last verified
- Sep 2025
- First submitted
- 1 Apr 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study
- ClinicalTrials.gov ID
- NCT06922175
- Acronym / sponsor ID
- 169(A)AV23432
- Keywords
- anti-seizure medications, Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- 1Med
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients affected by epilepsy with focal-onset seizures | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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;
- Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months).
Key exclusion criteria (8 listed)
- 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);
- Pregnancy or lactation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.
Time frame: 0-12 months
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
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines.
Time frame: 0-12 months
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
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines
Time frame: 0-12 months
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
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines
Time frame: 0-12 months
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;
10 secondary outcomes
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on the use of concomitant anti-seizure medications (ASMs)
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related emergency and medical care
Time frame: 0-12 months
Effectiveness of cenobamate used as adjunctive therapy
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on epilepsy-related surgery
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on comorbidity-related healthcare resources utilization (HCRU)
Time frame: 0-12 months
Impact of cenobamate used as adjunctive therapy on phone calls/virtual interventions
Time frame: 0-12 months
Safety of cenobamate used as adjunctive therapy
Time frame: 0-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
Related trials for Epilepsy With Uncontrolled Focal-onset Seizures
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Cenobamate in Adults With Focal-Onset Seizures
Epilepsy, Focal-Onset Seizure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy With Uncontrolled Focal-onset Seizures, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Spain, United Kingdom, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Nicklasson (+46 702528077, Lars.nicklasson@angelinipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of cenobamate used as adjunctive therapy on epilepsy-related healthcare resources utilization (HCRU), stratified by early and later treatment lines. (time frame: 0-12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.