This is a Retrospective Study on the Use of CENOBAMATE as Adjunctive Treatment in Patients Suffering From Epilepsy in Early Access Program in Germany, France and UK (CENOR)
Status
Conditions
Details and patient eligibility
About
Cenobamate is a newly-FDA and EMA approved drug used to treat -focal-onset seizures in adult patients.
The aim of the current study is to analyse retrospectively the overall effectiveness and tolerability of cenobamate from real-world data collected in patients who partecipated in the Early Access Program (EAP) and were treated with cenobamate as adjunctive ASM.
Full description
Cenobamate is a new approved drug used to treat -focal-onset seizures in adult patients. This novel tetrazole-derived carbamate seems to act primarily by two mechanisms that are commonly associated with epilepsy: cenobamate acts as a positive allosteric modulator of the GABAA ion channels and is effective in reducing repetitive neuronal firing by inhibition of voltage-gated sodium channels, although the complete mechanism of action is currently unknown.
In clinical trials, cenobamate showed also low toxicity and adverse drug reaction profile.
In European Union (EU), cenobamate received the marketing authorisation, valid throughout the EU, in March 2021. Starting from September 2020 an EAP was initiated with cenobamate as adjunctive ASM in several EU Countries such as Germany, France, and UK.
Real-world data are of importance to understand and confirm the efficacy and safety profile of drugs outside of the clinical trial setting. The aim of the current study is to analyse the overall effectiveness and tolerability of cenobamate from real-world data in a large series of patients treated with cenobamate as adjunctive ASM.
As a consequence, a retrospective collection and analysis of the data of the patients who participated in the EAP, according to the authorization received from the local regulatory or ethic authorities, was conducted.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Data from adult patients diagnosed with epilepsy with FOS participating in the EAP with cenobamate as adjunctive treatment, according to the authorization received from the local regulatory or ethic authorities will be collected and analyzed.
- Available data will be collected after obtaining consent from patient/legal representative to the processing of personal data according to the General Data Protection Regulation (GDPR) and applicable local regulation
Exclusion criteria
- Patient enrolled in other clinical trial during the EAP.
- Patient aged less than 18 years old.
- Patient with specific syndrome (e.g. LGS and Dravet)
Trial design
319 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Alessandro Comandini; Paola Lipone
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal