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Clinical Trials/NCT06380192
NCT06380192
Recruiting
Not Applicable

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

Imagine Institute23 sites in 1 country400 target enrollmentOctober 31, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Developmental and Epileptic Encephalopathy
Sponsor
Imagine Institute
Enrollment
400
Locations
23
Primary Endpoint
Identification of diagnostic and early predictive biomarkers of a neurodevelopmental trajectory with epileptic and developmental encephalopathies
Status
Recruiting
Last Updated
10 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2024
End Date
December 31, 2026
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Imagine Institute
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Identification of diagnostic and early predictive biomarkers of a neurodevelopmental trajectory with epileptic and developmental encephalopathies

Time Frame: Data 2002-2026

This composite outcome includes multiple diagnostic domains (Clinical, biological, radiological, genetic and electroencephalographic variables)

Secondary Outcomes

  • Assessment of patients' quality of life(Data 2002-2026)
  • Identification of patient subgroups presenting the identified biomarkers(Data 2002-2026)
  • Assessment of autism spectrum disorders(Data 2002-2026)
  • Assessment of age-related adaptive behavior(Data 2002-2026)
  • Assessment of behavioral disorders(Data 2002-2026)

Study Sites (23)

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