Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747001
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2023-01-30
Brief Title:
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
Sponsor:
Aziende Chimiche Riunite Angelini Francesco SpA
Organization:
Aziende Chimiche Riunite Angelini Francesco SpA
Study Overview
Official Title:
Retrospective Study on the Use of CENOBAMATE as Adjunctive Treatment in a Cohort of Patients Suffering From Epilepsy With Focal Onset Seizure FOS and Enrolled Into the Early Access Program EAP in Germany France and UK
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CENOR
Brief Summary:
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None