European Non-interventional Study on Refractory Epilepsy With Developmental Delay

Refractory Epilepsy Clinical Trial

Official title:

A European Non-interventional Study to Understand the Criteria Used and the Time Required for the Clinical Diagnosis in Participants With Refractory Epilepsies Associated With Developmental Delay

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04398667
• Other study ID #: 915-ENSURED
• Status: Terminated
• Start date: March 14, 2019
• Est. completion date: September 4, 2020

Study information

• Verified date: November 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Development Delay
• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Locations

Country	Name	City	State
France	Unité de neuropédiatrie, CHU Angers	Angers
France	Department of Neurology - Foundation John Bost	La Force
France	Hospital St Louis DRCI, CHU Bicêtre	Paris
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Institut der Diagnostik der Epilepsien	Berlin
Germany	Zentrum für Sozialpädiatrie und Neuropädiatrie (DBZ), Vivantes Klinikum	Berlin
Germany	Gesellschaft für Epilepsieforschung e. V.	Bielefeld
Germany	Klinik für Epileptologie, Universitätsklinikum Bonn	Bonn
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	Klinik für Neurologie, Heilig Geist-Krankenhaus GmbH	Köln
Germany	Epilepsiezentrum Kork	Kork
Germany	Department of Neurologie University of Magdeburg	Magdeburg
Germany	Abteilung für Epileptologie, ZfP Südwürttemberg	Ravensburg
Italy	I.R.C.C.S. Giannina Gaslini	Genova
Italy	Oasi Research Institute	Troina
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Ruber Internacional	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Zogenix, Inc.	Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With and Without Diagnosis of an Epilepsy Syndrome	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/	5 months
Primary	Understand the Clinical Practice Criteria	Understand the clinical practice criteria used for specific syndromic diagnosis of participants with refractory epilepsy associated with developmental delay.	5 months
Primary	Clinical Practice Diagnostic Criteria Compared to ILAE	Compare clinical practice diagnostic criteria to those proposed by the ILAE and identify potential areas of educational need.	5 months
Primary	Understand the Time to Formal Diagnosis	Understand the time to diagnosis, from first seizure to formal diagnosis of a specific syndrome.	5 months
Primary	Unclassified Epilepsy	Evaluate if unclassified epilepsy can be grouped with common electroclinical phenotype features.	5 months