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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

NCT ID: NCT05747001

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

319 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-27

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Focal Onset Seizure Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

Cohort of patients suffering from epilepsy with Focal Onset Seizure (FOS) and enrolled into the Early Access Program (EAP) in Germany, France and UK

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hippocrates Research

OTHER

Sponsor Role collaborator

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvain Rheims

Role: PRINCIPAL_INVESTIGATOR

Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon

Rhys Thoma

Role: PRINCIPAL_INVESTIGATOR

The Newcastle upon Tyne Hospitals NHS Trust Victoria Road, Newcastle, NE1 4LP

Felix Rosenow

Role: PRINCIPAL_INVESTIGATOR

Epilepsy Center Frankfurt Rhine-Main Neurocenter Schleusenweg 2 - 16 (Haus 95) 60528 Frankfurt am Main

Locations

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Hôpital Pierre Wertheimer - Hopsices Civils de Lyon

Bron, , France

Site Status

CHRU de Lille - Hôpital Roger Salengro (LILLE)

Lille, , France

Site Status

Centre Hospitalier Universitaire (CHU) de Marseille - Hopital de la Timone

Marseille, , France

Site Status

CHRU de Nancy -Hopital Central, Service de Neurologie

Nancy, , France

Site Status

Hôpital de la Pitié-Salpêtrière

Paris, , France

Site Status

CHU Rennes - Pontchaillou Hospital

Rennes, , France

Site Status

CHU de Rouen Hôpital Charles-NicolleService de Neurophysiologie

Rouen, , France

Site Status

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, , France

Site Status

Epilepsieklinik Tabor

Bernau bei Berlin, , Germany

Site Status

Epilepsy Center Bethel hospital Mara

Bielefeld, , Germany

Site Status

Klinik und Poliklinik für Epileptologie, Universitätsklinikum Bonn

Bonn, , Germany

Site Status

Neurologische Klinik

Erlangen, , Germany

Site Status

Epilepsy Center Frankfurt Rhine-Main Neurocenter

Frankfurt am Main, , Germany

Site Status

Klinik für Neurochirurgie Uniklinik Freiburg -

Freiburg im Breisgau, , Germany

Site Status

Evangelische Krankenhaus Alsterdorf

Hamburg, , Germany

Site Status

Diakonie Kork Epilepsiezentrum

Kehl, , Germany

Site Status

Epilepsiezentrum Hessen, Klinik für Neurologie, Philipps Universität Marburg - Standort Marburg

Marburg, , Germany

Site Status

Epilepsiezentrum Kleinwachau gGmbH

Radeberg, , Germany

Site Status

Neurologie - Stroke Unit - Zentrum für Epilepsie

Reinickendorf, , Germany

Site Status

Universitätsklinikum Tubingen

Tübingen, , Germany

Site Status

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

UCLH NHS Trust Epilepsy Department

London, , United Kingdom

Site Status

The Newcastle upon Tyne Hospitals

Newcastle, , United Kingdom

Site Status

Countries

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France Germany United Kingdom

Other Identifiers

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169(A)MD21350

Identifier Type: -

Identifier Source: org_study_id

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