At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 12 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks back at health records to see how the medicine cenobamate affects the use of healthcare services in adults with epilepsy whose focal-onset seizures (seizures starting in one part of the brain) are not controlled by other treatments. It is run by Aziende Chimiche Riunite Angelini Francesco S.p.A.
Who can take part
- Adults aged 18 or over, any ethnic origin, male or female
- Diagnosed epilepsy with uncontrolled focal-onset seizures despite trying 2 to 5 other anti-seizure medicines (ASMs)
- At least 1 seizure a month in the 6 months before starting cenobamate
- At least 6 months of medical record data before, and 12 months after, starting cenobamate
- Consent given for use of personal data under the GDPR or local rules
Who may not be able to
- Any condition that means adjunctive anti-seizure medicines should not be given, per their approved product information
- Started cenobamate through an early access programme
- Progressive neurological disease, such as degenerative brain diseases or growing brain tumours
- Certain syndromes, for example Lennox-Gastaut syndrome (LGS) or Dravet syndrome
- Pregnant or breastfeeding
- Unable to make decisions for themselves
- Current alcohol or substance misuse or dependence (caffeine and nicotine are allowed)
- Took part in an interventional study (drug or non-drug) in the 6 months before starting cenobamate
What taking part involves
- • Taking cenobamate, started on the index date (the study's starting point)
Time commitment: This is a retrospective study using existing medical records, so no extra visits or tests are stated — participants need consent to their data being used and must have at least 6 months of records before and 12 months after starting cenobamate.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 200
- Started
- 2024-12-19
- Last checked
- 2025-09
Plain English Summary
What is this study?
- • Testing a new treatment for epilepsy with uncontrolled focal-onset seizures
- • Clinical study - 200 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with epilepsy with uncontrolled focal-onset seizures
Where?
- • Glasgow - Institute of Neurosciences NHS Greater Glasgow and Clyde
- • Wolverhampton - Epilepsies - The Royal Wolverhampton NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ from 2 to 5 ASMs who started treatment with cenobamate at index date
What 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...
- ✓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...
Who cannot take part
- ✗Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved...
- ✗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;
See the full criteria
Where Is This Study? (2 UK sites)
Institute of Neurosciences NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Epilepsies - The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
How to Get in Touch
Lars Nicklasson
Sponsor contactCONTACT