Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data

NCT ID: NCT06380192

Last Updated: 2025-06-29

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-12-31

Brief Summary

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Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.

The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent.

Detailed Description

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Conditions

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Developmental and Epileptic Encephalopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient

Patient inclusion criteria:

* Diagnosis of developmental and epileptic encephalopathies
* Affiliation with, or beneficiary of, a social security scheme

Criteria for non-inclusion of patients:

* Opposition of the patient or his/her parents in the case of minors to the re-use of data for this study.
* Persons subject to a safeguard of justice measure

No interventions assigned to this group

Control patient

Inclusion criteria for controls:

* Patients who, as part of their routine health care, require an EEG examination
* Patients with sufficient follow-up to rule out a diagnosis of epilepsy, including developmental and epileptic encephalopathies
* Enrolled in or receiving social security benefits

Criteria for non-inclusion of controls :

* Patient with a neurological or extra-neurological disease that may have an impact on the child's neurological development and outcome
* Opposition of the patient or his/her parents to the re-use of data for this study
* Persons subject to a safeguard of justice measure

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Developmental and Epileptic Encephalopathy
* Registered with or benefiting from a social security scheme.

Exclusion Criteria

* Opposition of the patient or his/her parents to the re-use of data in the context of this study
* Person subject to a safeguard of justice measure
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imagine Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status NOT_YET_RECRUITING

CH Angers

Angers, , France

Site Status NOT_YET_RECRUITING

Chu Besancon

Besançon, , France

Site Status NOT_YET_RECRUITING

CHU Bordeaux

Bordeaux, , France

Site Status NOT_YET_RECRUITING

CHRU Brest

Brest, , France

Site Status NOT_YET_RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

CHU Grenoble

Grenoble, , France

Site Status NOT_YET_RECRUITING

CHU Lille

Lille, , France

Site Status NOT_YET_RECRUITING

CHU Limoges

Limoges, , France

Site Status NOT_YET_RECRUITING

CHU Lyon HCL

Lyon, , France

Site Status NOT_YET_RECRUITING

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status NOT_YET_RECRUITING

CHU de Nancy

Nancy, , France

Site Status NOT_YET_RECRUITING

Hopitaux Pediatriques de Nice CHU Lenval

Nice, , France

Site Status NOT_YET_RECRUITING

Necker-Enfants Malades Hospital

Paris, , France

Site Status RECRUITING

CHU Pitié Salpétrière

Paris, , France

Site Status NOT_YET_RECRUITING

CHU Robert Debré

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Armand Trousseau

Paris, , France

Site Status NOT_YET_RECRUITING

Chu Reims

Reims, , France

Site Status NOT_YET_RECRUITING

CHU Rennes

Rennes, , France

Site Status NOT_YET_RECRUITING

CHU Strasbourg

Strasbourg, , France

Site Status NOT_YET_RECRUITING

CHU Toulouse

Toulouse, , France

Site Status NOT_YET_RECRUITING

CHRU Tours

Tours, , France

Site Status NOT_YET_RECRUITING

Hôpital André Mignot (CH Versailles)

Versailles, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Rima Nabbout, Pr

Role: CONTACT

+33144381536

Facility Contacts

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William Szurhaj, Pr

Role: primary

Patrick Van Bogaert, Pr

Role: primary

Cécilia Altuzala, Dr

Role: primary

Frédéric Villéga, Dr

Role: primary

Jérémie Lefranc, Dr

Role: primary

Gaëlle REMERAND, Dr

Role: primary

Fanny Dubois, Dr

Role: primary

+33 (0)4 76 76 57 03

Sylvie NGUYEN THE TICH, Pr

Role: primary

Cécile Laroche, Dr

Role: primary

Dorothee Ville, Dr

Role: primary

Mathieu Milh, Pr

Role: primary

Mathieu Kuchenbuch, Dr

Role: primary

Julien NEVEU, Dr

Role: primary

+33 (0)4 92 03 03 92

Rima Nabbout, Pr

Role: primary

+33 (0)1 44381536

Vincent Navarro, Pr

Role: primary

Stephane Auvin, Pr

Role: primary

Cyril MIGNOT, Dr

Role: primary

Melanie JENNESSON, Dr

Role: primary

Sylvia Napuri-peirano, Dr

Role: primary

Anne De Saint Martin, Dr

Role: primary

+33 (0)3 88 12 83 98

Caroline HACHON-LE CAMUS, Dr

Role: primary

Maximilien PERIVIER, Dr

Role: primary

Samer WEHBI, Dr

Role: primary

Other Identifiers

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HJ22-DEE-RETRO

Identifier Type: -

Identifier Source: org_study_id

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