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The clinical research organization went out of business.
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| Name | Class |
|---|---|
| Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | INDUSTRY |
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This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Understand the Time to Formal Diagnosis | Understand the time to diagnosis, from first seizure to formal diagnosis of a specific syndrome. | 5 months |
| Unclassified Epilepsy | Evaluate if unclassified epilepsy can be grouped with common electroclinical phenotype features. | 5 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with rare epilepsy syndromes up to the date of the most recent visit at the study site.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unité de neuropédiatrie, CHU Angers | Angers | France | ||||
| Department of Neurology - Foundation John Bost |
| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D003147 |
| Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |