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

NCT05747001 | Completed

• 1 other identifier: 169(A)MD21350
• Study Type: observational
• Target: 319
• Locations: 3 countries
• Sites: 23

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.

Conditions

Focal Onset Seizure; Epilepsy

Keywords

epilepsy; FOS; cenobamate; retrospective; Early Access Program; Europe

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Portion of responders

  1 and 3 months after start of cenobamate therapy

• Portion of responders

  3, 6 and 12 months after the completion of the titration and its relation with the dosage.

• Portion of seizure free

  1 and 3 months after start of cenobamate therapy

• Portion of seizure free

  3, 6 and 12 months after the completion of the titration and its relation with the dosage.

• Retention rate

  1 and 3 months after start of cenobamate therapy

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients suffering from epilepsy with FOS who have been treated with cenobamate as adjunctive Anti-seizure medication (ASM) during the EAP in Germany, France and UK.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Hippocrates Research: collaborator

Study Sites (23)

Hôpital Pierre Wertheimer - Hopsices Civils de Lyon

Bron, 69677, France

Location

CHRU de Lille - Hôpital Roger Salengro (LILLE)

Lille, 59037, France

Location

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

Marseille, 13005, France

Location

CHRU de Nancy -Hopital Central, Service de Neurologie

Nancy, 54000, France

Location

Hôpital de la Pitié-Salpêtrière

Paris, 75013, France

Location

CHU Rennes - Pontchaillou Hospital

Rennes, 35000, France

Location

CHU de Rouen Hôpital Charles-NicolleService de Neurophysiologie

Rouen, 76000, France

Location

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Epilepsieklinik Tabor

Bernau bei Berlin, 16321, Germany

Location

Epilepsy Center Bethel hospital Mara

Bielefeld, 33617, Germany

Location

Klinik und Poliklinik für Epileptologie, Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Neurologische Klinik

Erlangen, 91054, Germany

Location

Epilepsy Center Frankfurt Rhine-Main Neurocenter

Frankfurt am Main, 60528, Germany

Location

Klinik für Neurochirurgie Uniklinik Freiburg -

Freiburg im Breisgau, 79106, Germany

Location

Evangelische Krankenhaus Alsterdorf

Hamburg, 22297, Germany

Location

Diakonie Kork Epilepsiezentrum

Kehl, 77694, Germany

Location

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

Marburg, 35043, Germany

Location

Epilepsiezentrum Kleinwachau gGmbH

Radeberg, 01454, Germany

Location

Neurologie - Stroke Unit - Zentrum für Epilepsie

Reinickendorf, 13509, Germany

Location

Universitätsklinikum Tubingen

Tübingen, 72016, Germany

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

UCLH NHS Trust Epilepsy Department

London, WC1N 3BG, United Kingdom

Location

The Newcastle upon Tyne Hospitals

Newcastle, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Seizures; Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Sylvain Rheims

  Hôpital Neurologique Pierre Wertheimer - Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• Rhys Thoma

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

  PRINCIPAL INVESTIGATOR

• Felix Rosenow

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 28, 2023
• Study Start: January 27, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 9, 2024

Record last verified: 2023-03

Locations

DE (12); GB (3); FR (8)