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Study identifier: NCT06625112 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Multicentric European Study to Promote Clinical Trial Readiness for STXBP1-related Disorders

Condition: STXBP1 Encephalopathy With Epilepsy  ·  Sponsor: European STXBP1 Consortium

PhaseN/A
Planned participants120
Who can joinAll sexes, N/A to no upper limit
Healthy volunteersNo

About this study

STXBP1-related disorders (STXBP1-RD) are rare genetic neurodevelopmental disorders, caused by pathogenic variants in the gene STXBP1. The core clinical features of the disorder are developmental delay often leading to (severe) intellectual disability and seizures in most patients, although the phenotypic spectrum is variable. Behavioral problems and movement disorders are frequent comorbidities. STXBP1-RD are severe disorders with significant impact on the quality of life of the patients and their caregivers. At the moment, there is no cure for STXBP1-RD and treatment is largely limited to symptom control. Recent advances in the field of precision medicine and gene therapy have led to the identification of potential novel disease modifying therapies for STXBP1-RD that hold promise to reach clinical trials in the coming years. However, accurate and successful evaluation of such novel precision therapies in STXBP1-RD patients is challenging, given the rarity of the condition and the variable clinical spectrum. Furthermore, relevant clinical endpoints, taking into account the patients' and caregivers' perspective have not been identified to date. In this European collaborative study, the investigators will prospectively follow patients with STXBP1-RD during different phases of life (infantile period, childhood and adolescence/adulthood). The study aims to better understand the natural history and the phenotypic spectrum of the disease including the identification of disease mod…

This description comes directly from the study's public registry record.

Talk to the study team

Kelsey Ax  ·  +31 205981347  ·  k.a.ax@vu.nl

Hannah Stamberger  ·  Hannah.Stamberger@uantwerpen.vib.be

Always discuss trial participation with your own doctor first.

Locations (1)

Universitair Ziekenhuis AntwerpenAntwerp, BelgiumRecruiting

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Source record: clinicaltrials.gov/study/NCT06625112