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NCT06356233: FIMBEX

Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy

Not yet recruiting Last updated 10 April 2024
What this trial tests

trial testing No intervention will be performed in STXBP1 Encephalopathy With Epilepsy in 10 participants. Not yet recruiting.

Timeline
1 May 2024
Primary endpoint
1 October 2027
31 December 2027

Quick facts

Lead sponsorFundación Iniciativa para las Neurociencias (FINCE)
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment10
Start date1 May 2024
Primary completion1 October 2027
Estimated completion31 December 2027
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Fundación Iniciativa para las Neurociencias (FINCE)

Who can join

Adults 1 Month to 10, any sex, with STXBP1 Encephalopathy With Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of No intervention will be performed

Trials testing the same drug.

Other recruiting trials for STXBP1 Encephalopathy With Epilepsy

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06356233.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing