European Non-interventional Study on Refractory Epilepsy With Developmental Delay

NCT04398667 | Terminated DMC

• 1 other identifier: 915-ENSURED
• Study Type: observational
• Target: 93
• Locations: 4 countries
• Sites: 19

Brief Summary

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

Conditions

Refractory Epilepsy; Development Delay

Keywords

Observational; Retrospective

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with rare epilepsy syndromes up to the date of the most recent visit at the study site.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zogenix, Inc.: lead
• Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.: collaborator

Study Sites (19)

Unité de neuropédiatrie, CHU Angers

Angers, France

Location

Department of Neurology - Foundation John Bost

La Force, France

Location

Hospital St Louis DRCI, CHU Bicêtre

Paris, France

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Institut der Diagnostik der Epilepsien

Berlin, Germany

Location

Zentrum für Sozialpädiatrie und Neuropädiatrie (DBZ), Vivantes Klinikum

Berlin, Germany

Location

Gesellschaft für Epilepsieforschung e. V.

Bielefeld, Germany

Location

Klinik für Epileptologie, Universitätsklinikum Bonn

Bonn, Germany

Location

Klinik für Neurologie, Heilig Geist-Krankenhaus GmbH

Cologne, Germany

Location

Klinik Für Kinder- und Jugendmedizin, Neuropadiatrie und Epilepsiezentrum

Frankfurt, Germany

Location

Department of Neurology / Epileptology, University Medicine Greifswald

Greifswald, Germany

Location

Klinik für Kinder-und Jugendmedizin II, Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Location

Epilepsiezentrum Kork

Kork, Germany

Location

Department of Neurologie University of Magdeburg

Magdeburg, Germany

Location

Abteilung für Epileptologie, ZfP Südwürttemberg

Ravensburg, Germany

Location

I.R.C.C.S. Giannina Gaslini

Genova, Italy

Location

Oasi Research Institute

Troina, Italy

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Ruber Internacional

Madrid, Spain

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Learning Disabilities

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

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

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: March 14, 2019
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

ES (2); DE (12); IT (2); FR (3)