Actively Recruiting
REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
Led by Aziende Chimiche Riunite Angelini Francesco S.p.A · Updated on 2025-10-02
200
Participants Needed
10
Research Sites
53 weeks
Total Duration
On this page
Sponsors
A
Aziende Chimiche Riunite Angelini Francesco S.p.A
Lead Sponsor
1
1Med
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients of any ethnic origin 18 years old or older at index date
- Diagnosis of epilepsy with uncontrolled focal-onset seizures despite treatment with 2 to 5 anti-seizure medications
- At least 1 seizure per month in the last 6 months before index date
- At least 6 months of medical record data before the index date
- At least 12 months of medical record data after the index date, with no data gaps longer than 6 months
- Consent to data processing according to GDPR or applicable local regulations
You will not qualify if you...
- Contraindications to adjunctive anti-seizure medications according to approved prescribing information
- Started cenobamate within an early access program
- Progressive neurological diseases including degenerative CNS diseases or progressive brain tumors
- Specific syndromes such as Lennox-Gastaut Syndrome (LGS) or Dravet syndrome
- Pregnancy or breastfeeding
- Lack of self-judgement ability
- Substance or alcohol abuse or dependence, except caffeine and nicotine
- Participation in any interventional study starting within 6 months before the index date
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, Germany
Not Yet Recruiting
2
Epileptologicum
Hamburg, Germany, Germany
Not Yet Recruiting
3
Diakonie Kork, Epilepsiezentrum
Kork, Germany, Germany
Not Yet Recruiting
4
Kempenhaeghe - Academisch Centrum voor Epilepsie
Heeze, Netherlands, Netherlands
Not Yet Recruiting
5
Epilepsy Unit - Neurology Department Valle de Hebron Hospital
Barcelona, Spain, Spain
Actively Recruiting
6
Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos
Madrid, Spain, Spain
Actively Recruiting
7
Consorcio Hosp. General Universitario Valencia
Valencia, Spain, Spain
Actively Recruiting
8
Department of Neurology, University Hospital Zurich
Zurich, Switzerland, Switzerland
Actively Recruiting
9
Institute of Neurosciences NHS Greater Glasgow and Clyde
Glasgow, UK, United Kingdom
Actively Recruiting
10
Epilepsies - The Royal Wolverhampton NHS Trust
Wolverhampton, UK, United Kingdom
Actively Recruiting
Research Team
L
Lars Nicklasson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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