Actively Recruiting
Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain
Led by Aziende Chimiche Riunite Angelini Francesco S.p.A · Updated on 2025-09-19
300
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
Sponsors
A
Aziende Chimiche Riunite Angelini Francesco S.p.A
Lead Sponsor
I
IQVIA Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).
CONDITIONS
Official Title
Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 18 years or older at the time of cenobamate treatment initiation
- Diagnosis of epilepsy with focal-onset seizures, with or without secondary generalization
- Under titration phase with cenobamate as adjunctive therapy in third or fourth line with 1 to 3 concomitant anti-seizure medications
- Not adequately controlled despite treatment with 2 or 3 anti-seizure medications before starting cenobamate
- Available retrospective data including reliable seizure frequency information for the last 3 months before cenobamate treatment
- Signed written informed consent prior to entering the study following local regulations
You will not qualify if you...
- Contraindications to cenobamate as per its approved Summary of Product Characteristics
- Progressive neurodegenerative central nervous system diseases or brain tumors
- Unstable psychiatric diagnosis including recent suicidal ideation, current psychotic disorder, or acute mania
- Known substance abuse or dependence, except caffeine and nicotine
- Participation in any interventional study from cenobamate treatment initiation until enrollment
- Ongoing pregnancy or breastfeeding from cenobamate treatment initiation until enrollment
- Seizure-free in the last 3 months before starting cenobamate treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital TARNIER COCHIN
Paris, France, France
Actively Recruiting
Research Team
V
Valeria Tellone
CONTACT
E
Enrica Salvatori
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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