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Patient-reported, Health Economic and Psychosocial Outcomes in Friedreich Ataxia

Recruitingn/aAges 12 Years - anyAllGerman Center for Neurodegenerative Diseases (DZN…
NCT05943002 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The PROFA study is an international, multi-centric observational and validation study to assess the patient-reported, psychosocial and economic outcomes of patients with Friedreich Ataxia (FA). Eligible patients will be recruited from six study centers in Germany, Austria and France. Patients will complete a baseline assessment via face-to-face interviews at the study centers and multiple momentary follow-up assessments via a mobile-health app at home daily to monthly for six months. Study results will gain essential and in-depth insights into the daily life of patients with FA.

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📋 Eligibility rules (as published)
Inclusion Criteria: * FA confirmed by molecular genetic testing * Ataxia severity of ≤30 points according to the Scale of the Assessment and Rating of Ataxia (SARA) * Access to a smartphone or tablet and able to operate the device * Older than 12 years Exclusion Criteria: * Lack of ability to give consent * Ataxia severity \>30 according to the Scale of the Assessment and Rating of Ataxia (SARA)
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What it tests

  • Not listed
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Where

6 sites
Klinik für Neurologie, Medizinische Universität Innsbruck
Innsbruck, Austria
Paris Brain Institute
Paris, France
Department of Neurology, RWTH Aachen University
Aachen, Germany
German Center for Neuro-degenerative Diseases (DZNE)
Bonn, Germany
Friedrich-Baur-Institut an der Neurologischen Klinik und Poliklinik
Münich, Germany
Neurologische Klinik und Hertie-Institut für Klinische Hirnforschung, Universitätsklinik Tübingen
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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