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RECRUITING
NCT05177809

RFC1 Natural History Study

Sponsor: Prof. Dr. Matthis Synofzik

View on ClinicalTrials.gov

Summary

This international, multi-center, multi-modal and prospective observational study aims to determine the phenotypic spectrum and the natural progression of the RFC1 repeat expansion disease, and to seek and validate digital, imaging, and molecular biomarkers that aid in diagnosis and serve as outcome measures in future clinical trials of this novel, but frequent ataxia with late adult-onset.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2021-12-14

Completion Date

2026-12

Last Updated

2026-03-31

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Clinical rating scale to measure ataxia disease severity and progression

SARA is a clinical scale developed by Schmitz-Hübsch et al which assesses a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.

Locations (10)

Department of Neuroscience, Central Clinical School, Monash University

Melbourne, Victoria, Australia

Department of Neurology, Ataxia Unit, Universidade Federal de São Paulo

São Paulo, State of São Paulo, Brazil

Service de Neurologie, Hôpitaux Universitaires de Strasbourg

Strasbourg, Strasbourg, France

Center for Neurology & Hertie-Institute for Clinical Brain Research, Dept. for Neurodegenerative Diseases

Tübingen, Baden-Wurttemberg, Germany

German Center for Neurodegenerative Diseases (DZNE)

Bonn, North Rhine-Westphalia, Germany

Department of Neurology University Hospital Schleswig Holstein

Lübeck, Schleswig-Holstein, Germany

Università degli Studi di Napoli 'Federico II', c/o AOU Federico II

Naples, Napoli, Italy

IRCCS Fondazione Stella Maris

Pisa, Italy

Centre of Brain Research Neurogenetics Research Clinic, University of Auckland

Auckland, New Zealand

Koç University Hospital, KUTTAM-NDAL

Istanbul, Turkey (Türkiye)