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Recruiting NCT06380192

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

Observational Developmental and Epileptic Encephalopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Developmental and Epileptic Encephalopathy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data / DEE-RETRO

Overview

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.

Primary outcome measures

  • Identification of diagnostic and early predictive biomarkers of a neurodevelopmental trajectory with epileptic and developmental encephalopathies [Time frame: Data 2002-2026]
Secondary outcome measures (5)
  • Identification of patient subgroups presenting the identified biomarkers [Time frame: Data 2002-2026]
  • Assessment of patients' quality of life [Time frame: Data 2002-2026]
  • Assessment of age-related adaptive behavior [Time frame: Data 2002-2026]
  • Assessment of behavioral disorders [Time frame: Data 2002-2026]
  • Assessment of autism spectrum disorders [Time frame: Data 2002-2026]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 23 centers
  • CHU Amiens — Amiens
  • CH Angers — Angers
  • Chu Besancon — Besançon
  • CHU Bordeaux — Bordeaux
  • CHRU Brest — Brest
  • CHU Clermont-Ferrand — Clermont-Ferrand
  • CHU Grenoble — Grenoble
  • CHU Lille — Lille
  • … and 15 more centers

Identifiers

NCT: NCT06380192 · HJ22-DEE-RETRO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗