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

Epilepsy Clinical Trial

— CENOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747001
• Other study ID #: 169(A)MD21350
• Status: Completed
• Start date: January 27, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Locations

Country	Name	City	State
France	Hôpital Pierre Wertheimer - Hopsices Civils de Lyon	Bron
France	CHRU de Lille - Hôpital Roger Salengro (LILLE)	Lille Cedex
France	Centre Hospitalier Universitaire (CHU) de Marseille - Hopital de la Timone	Marseille
France	CHRU de Nancy -Hopital Central, Service de Neurologie	Nancy
France	Hôpital de la Pitié-Salpêtrière	Paris
France	CHU Rennes - Pontchaillou Hospital	Rennes
France	CHU de Rouen Hôpital Charles-NicolleService de Neurophysiologie	Rouen
France	CHU de Strasbourg - Hôpital de Hautepierre	Strasbourg
Germany	Neurologie - Stroke Unit - Zentrum für Epilepsie	Berlin-Reinickendorf
Germany	Epilepsieklinik Tabor	Bernau bei Berlin
Germany	Epilepsy Center Bethel hospital Mara	Bielefeld
Germany	Klinik und Poliklinik für Epileptologie, Universitätsklinikum Bonn	Bonn
Germany	Neurologische Klinik	Erlangen
Germany	Epilepsy Center Frankfurt Rhine-Main Neurocenter	Frankfurt am main
Germany	Klinik für Neurochirurgie Uniklinik Freiburg -	Freiburg
Germany	Evangelische Krankenhaus Alsterdorf	Hamburg
Germany	Diakonie Kork Epilepsiezentrum	Kehl
Germany	Epilepsiezentrum Hessen, Klinik für Neurologie, Philipps Universität Marburg - Standort Marburg	Marburg
Germany	Epilepsiezentrum Kleinwachau gGmbH	Radeberg
Germany	Universitätsklinikum Tubingen	Tübingen
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	UCLH NHS Trust Epilepsy Department	London
United Kingdom	The Newcastle upon Tyne Hospitals	Newcastle

Sponsors (2)

Lead Sponsor	Collaborator
Aziende Chimiche Riunite Angelini Francesco S.p.A	Hippocrates Research

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate (%) at 3 months from the start of maintenance	Percentage of responder rate (defined as a =50% reduction from screening/baseline in focal onset seizure frequency) after 3 months of maintenance phase.	3 months from the start of maintenance
Secondary	Portion of responders	Portion of responders (defined as a =50% and <100% reduction from screening/baseline in focal onset seizure frequency) at 1 and 3 months after start of cenobamate therapy	1 and 3 months after start of cenobamate therapy
Secondary	Portion of responders	Portion of responders (defined as a =50% and <100% reduction from screening/baseline in focal onset seizure frequency) at 3, 6 and 12 months after the completion of the titration and its relation with the dosage.	3, 6 and 12 months after the completion of the titration and its relation with the dosage.
Secondary	Portion of seizure free	Portion of seizure free (100% reduction from screening/baseline) 1 and 3 months after start of cenobamate therapy	1 and 3 months after start of cenobamate therapy
Secondary	Portion of seizure free	Portion of seizure free (100% reduction from screening/baseline)3, 6 and 12 months after the completion of the titration and its relation with the dosage.	3, 6 and 12 months after the completion of the titration and its relation with the dosage.
Secondary	Retention rate	Retention rate measured as percentage of patients remaining in the study and on adjunctive therapy at: 1 and 3 months after start of cenobamate therapy	1 and 3 months after start of cenobamate therapy
Secondary	Retention rate	Retention rate measured as percentage of patients remaining in the study and on adjunctive therapy at 3, 6 and 12 months after the completion of the titration and its relation with the dosage.	3, 6 and 12 months after the completion of the titration
Secondary	No. of Adverse Reactions (ADRs),	Adverse Reactions (ADRs), including DRESS, rash/hypersensitivity occurred during the EAP.	Through study completion, an average of 2 years
Secondary	Change in Seizures Frequency	Change in Seizures Frequency at 1 and 3 months after start of cenobamate therapy,	1 and 3 months after start of cenobamate therapy
Secondary	Change in Seizures Frequency	Change in Seizures Frequency at 3, 6 and 12 months after the completion of the titration	3, 6 and 12 months after the completion of the titration
Secondary	Assessment of quality of life	The quality of life was assessed through the Questionnaire Quality of Life in Epilepsy Inventory - 31 items	1 and 3 months after start of cenobamate therapy
Secondary	Assessment of quality of life	The quality of life was assessed through the Questionnaire Quality of Life in Epilepsy Inventory - 31 items	3, 6 and 12 months after the completion of the titration