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NCT06922175Recruiting

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

Retrospective Evaluation of Cenobamate's Health Care Resources Utilization (HCRU) in the Management of Uncontrolled Focal Onset Seizures- A Retrospective, Chart Review Study

Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
1 Apr 2025
Start date
19 Dec 2024
Primary completion date
30 Dec 2025
Lead sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Diseases
Epilepsy
NCT number
NCT06922175

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 19 Dec 2024 to the primary completion date, 30 Dec 2025
  • 10 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.

Other illness

  • Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors;
  • Patients with specific syndrome (e.g. LGS and Dravet);

Other

  • 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;
  • Pregnancy or lactation;
  • Patients without self-judgement ability;
  • Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine);

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Neurology, University Hospital Zurich
Coordinator of this site? Confirm its status
ZurichSwitzerlandRecruiting
Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg
Coordinator of this site? Confirm its status
Freiburg im BreisgauGermanyNot yet recruiting
Epileptologicum
Coordinator of this site? Confirm its status
HamburgGermanyNot yet recruiting
Diakonie Kork, Epilepsiezentrum
Coordinator of this site? Confirm its status
KorkGermanyNot yet recruiting
Epilepsy Unit - Neurology Department Valle de Hebron Hospital
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Consorcio Hosp. General Universitario Valencia
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Institute of Neurosciences NHS Greater Glasgow and Clyde
Coordinator of this site? Confirm its status
GlasgowUnited KingdomRecruiting
Epilepsies - The Royal Wolverhampton NHS Trust
Coordinator of this site? Confirm its status
WolverhamptonUnited KingdomRecruiting
Kempenhaeghe - Academisch Centrum voor Epilepsie
Coordinator of this site? Confirm its status
HeezeNetherlandsNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.