NCT06356233|Not Yet Recruiting
Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy
FIMBEX
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FIMBEX
Sponsor study identifier
observational
10
1 country
1
Study Start
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 4, 2024
Actual (reported)April 10, 2024
Actual (reported)May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
CSF biomarkers
Baseline, 1 year and 2 years
EEG markers
Baseline, 1 year and 2 years
MRI markers
Baseline, 1 year and 2 years
Clinical phenotype
Baseline, 1 year and 2 years
No intervention will be performed
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients under 10 years of age with confirmed mutation for STXBP1 willing to collaborate in the study.
Hospital Ruber Internacional
Madrid, 28034, Spain
CSF
First Submitted
April 4, 2024
First Posted
April 10, 2024
Study Start
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2027
Herpes Simplex Reactivation in Adult Critical Care Patients
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 10, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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