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Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy

Study acronym: FIMBEX
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

  1. Study First Submitted
This is a prospective observational study to evaluate the phenotype of 10 patients under 10 years of age with developmental epileptic encephalopathy due to mutation of the STXBP1 gene. The study will consist of a clinical and neurodevelopmental evaluation, magnetic resonance imaging, prolonged electroencephalogram, cardiological study, and analysis of biomarkers in cerebrospinal fluid. These patients will be followed up for 3 years. The aim of the study is, knowing the baseline phenotype, to analyse the response to commonly used drugs and to anticipate the response to different drugs available on the market in this group of patients based on clinical and biomarker assessment (EEG, MRI and study of specific proteins and neurotransmitters in plasma, urine and CSF).
Trial Details
NCT Number NCT06356233
Lead Sponsor Fundación Iniciativa para las Neurociencias (FINCE)
Conditions
(from sponsor)		 STXBP1 Encephalopathy With Epilepsy
Related terms Epileptic Encephalopathy, Early Infantile, 4
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov