European Non-interventional Study on Refractory Epilepsy With Developmental Delay

Terminated

• Conditions: Refractory Epilepsy; Development Delay

• Registration Number: NCT04398667
• Lead Sponsor: Zogenix, Inc.

Brief Summary

This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).

Detailed Description

This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review). The identified local site staff (or trained independent data abstractors, if requested by the site) will review the medical records of all participants meeting the eligibility criteria, who have provided a signed inform consent form (ICF) for data collection and analysis. For participants who are less than 18 years of age, in addition to the assent form being signed by the participant, an informed consent would be obtained from parental or legally authorized representative.

In line with the retrospective nature of the study: there is no assignment of a participant to a particular therapeutic strategy; no additional diagnostic or monitoring procedures shall be applied to the participants; epidemiological methods shall be used for the analysis of collected data; the prescription of any medication for the treatment of the epileptic syndrome occur before the collection of the data in this study and is clearly separated from the decision to include the participant in the study.

Study Timeline

• Study Start: 2019-03-14
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-21
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Age ≥2 years
• Disease history of at least 24 months from date of first seizure
• Medical history of epilepsy associated with moderate to severe intellectual disability, cognitive developmental delay or cognitive regression
• Medical history of onset of seizures in early childhood (≤ 8 years)
• Failure of adequate trials of two tolerated and appropriately chosen and used Anti-Epileptic Drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom
• Ongoing refractory epilepsy
• MRI and EEG data are available for the participant
• Participants (or their parents/ legal representative as appropriate) have provided written informed consent / assent form to collect the data specified.

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Exclusion Criteria

• Normal cognitive development.
• Any acute symptomatic seizures in participants with underlying developmental delay.
• Any progressive intellectual and neurological deterioration conditions.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Understand the Clinical Practice Criteria	5 months	Understand the clinical practice criteria used for specific syndromic diagnosis of participants with refractory epilepsy associated with developmental delay.
Proportion of Participants With and Without Diagnosis of an Epilepsy Syndrome	5 months	Understand the proportion of participants with and without diagnosis of an epilepsy syndrome, as described by the International League Against Epilepsy (ILAE) diagnostic manual located at https://www.epilepsydiagnosis.org/
Understand the Time to Formal Diagnosis	5 months	Understand the time to diagnosis, from first seizure to formal diagnosis of a specific syndrome.
Unclassified Epilepsy	5 months	Evaluate if unclassified epilepsy can be grouped with common electroclinical phenotype features.
Clinical Practice Diagnostic Criteria Compared to ILAE	5 months	Compare clinical practice diagnostic criteria to those proposed by the ILAE and identify potential areas of educational need.

Trial Locations

Locations (19)

Gesellschaft für Epilepsieforschung e. V.; 🇩🇪 Bielefeld, Germany

Unité de neuropédiatrie, CHU Angers; 🇫🇷 Angers, France

Department of Neurology - Foundation John Bost; 🇫🇷 La Force, France

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Hospital St Louis DRCI, CHU Bicêtre; 🇫🇷 Paris, France

Klinik für Epileptologie, Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Institut der Diagnostik der Epilepsien; 🇩🇪 Berlin, Germany

Zentrum für Sozialpädiatrie und Neuropädiatrie (DBZ), Vivantes Klinikum; 🇩🇪 Berlin, Germany

Klinik Für Kinder- und Jugendmedizin, Neuropadiatrie und Epilepsiezentrum; 🇩🇪 Frankfurt, Germany

Department of Neurology / Epileptology, University Medicine Greifswald; 🇩🇪 Greifswald, Germany

Klinik für Kinder-und Jugendmedizin II, Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Epilepsiezentrum Kork; 🇩🇪 Kork, Germany

Department of Neurologie University of Magdeburg; 🇩🇪 Magdeburg, Germany

Klinik für Neurologie, Heilig Geist-Krankenhaus GmbH; 🇩🇪 Köln, Germany

Abteilung für Epileptologie, ZfP Südwürttemberg; 🇩🇪 Ravensburg, Germany

Oasi Research Institute; 🇮🇹 Troina, Italy

I.R.C.C.S. Giannina Gaslini; 🇮🇹 Genova, Italy

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Ruber Internacional; 🇪🇸 Madrid, Spain