European Non-interventional Study on Refractory Epilepsy With Developmental Delay
NCT ID: NCT04398667
Last Updated: 2023-12-01
Study Results
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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TERMINATED
93 participants
OBSERVATIONAL
2019-03-14
2020-09-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Any acute symptomatic seizures in participants with underlying developmental delay.
* Any progressive intellectual and neurological deterioration conditions.
2 Years
ALL
No
Sponsors
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Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
INDUSTRY
Zogenix, Inc.
INDUSTRY
Responsible Party
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Locations
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Unité de neuropédiatrie, CHU Angers
Angers, , France
Department of Neurology - Foundation John Bost
La Force, , France
Hospital St Louis DRCI, CHU Bicêtre
Paris, , France
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 Neurologie, Heilig Geist-Krankenhaus GmbH
Cologne, , 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
Abteilung für Epileptologie, ZfP Südwürttemberg
Ravensburg, , Germany
I.R.C.C.S. Giannina Gaslini
Genova, , Italy
Oasi Research Institute
Troina, , Italy
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Ruber Internacional
Madrid, , Spain
Countries
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Other Identifiers
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915-ENSURED
Identifier Type: -
Identifier Source: org_study_id