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

Study acronym: DEE-RETRO
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary endpoints: 2 to 1
    • Study sites: 20 to 23
    • Start date: Dec 1, 2024 to Oct 31, 2024
    v4
  2. Primary endpoints revised (2)
    • Study sites: 1 to 20
    • Eligibility criteria shortened, about 5 words
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary and study completion dates: Mar 31, 2026 to Dec 31, 2026
    • Start date changed from estimate of May 1, 2024 to Dec 1, 2024
    • Primary endpoints revised (2)
    • Study sites: 0 to 1
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06380192
Lead Sponsor Imagine Institute
Conditions
(from sponsor)		 Developmental and Epileptic Encephalopathy
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov