Sporadic Degenerative Ataxia With Adult Onset: Natural History Study

Recruiting now

Conditions studied: Late Onset Sporadic Cerebellar Ataxia

In brief

The key goals of SPORTAX-NHS is to compare the phenotype of multiple system atrophy of cerebellar type (MSA-C) and sporadic adult onset ataxia of unknown aetiology (SAOA) and to determine the rate of disease progression in both groups including determination of the factors that predict the development of MSA-C vs. SAOA, and at which time after onset of ataxia, a reliable distinction between both disorders is possible. The planned study will also allow to collect blood samples and other biomaterials from patients with sporadic ataxia, which will be useful for future genetic and biomarker studies.

Key facts

Study ID

NCT02701036

Run by

Ataxia Study Group

People needed

300

Starts

2010-04-01

Expected to finish

2030-12-01

Last updated by the study team

2017-06-29

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Progressive ataxia
• Disease onset after the age of 40 years
• Informative and negative family history (no similar disorders in first- and second-degree relatives; parents older than 50 years, or, if not alive, age at death of more than 50 years, no consanguinity of parents)

You may not qualify if…

• No established acquired cause of ataxia
• Clinical exclusion criteria:
• No onset of ataxia in association with stroke, encephalitis, sepsis, hyperthermia or heat stroke;
• no chronic diarrhea;
• no unexplained visual loss;
• no alcohol abuse;
• no chronic intake of anticonvulsant drugs;
• no other toxic causes; no malignancies;
• no rapid progression (development of severe ataxia in less than 12 weeks);
• no insulin-dependent diabetes mellitus
• Imaging exclusion criteria:
• No evidence of multiple sclerosis, ischemia, hemorrhage or tumor of the posterior fossa;
• absence of signal abnormalities on T2/FLAIR-images except abnormalities compatible with MSA
• Laboratory exclusion criteria:
• Negative molecular genetic testing for FRDA (only required if there is no cerebellar atrophy on MRI, SCA1, SCA2, SCA3, SCA6, FMR1 premutation (only required if prominent tremor, cognitive impairment and signal abnormality on T2/FLAIR images in the middle cerebellar peduncle);
• antineuronal antibodies negative (only required, if disease duration less than 3 years);
• normal levels of vitamin B12;
• VDRL negative;
• normal thyreoid function

Where it is running

• Oslo University Hospital — Oslo, Norway (enrolling)
• Universitätsmedizin Berlin Charité — Berlin, Germany (enrolling)
• Department of Neurology, University of Bonn — Bonn, Germany (enrolling)
• Department of Neurology, University Clinic Essen, University of Duisburg-Essen — Essen, Germany (enrolling)
• Department of Neurology, University of Frankfurt — Frankfurt, Germany (enrolling)
• Friedrich-Baur-Institut an der Neurologischen Klinik — München, Germany (enrolling)
• Universitätsmedidzin Rostock - Klinik und Poliklinik für Neurologie — Rostock, Germany (enrolling)
• Dept. of Neurodegenerative Diseases Tübingen — Tübingen, Germany (enrolling)
• Department of Neuroscience, Federico II University Naples — Naples, Italy (enrolling)
• Otto-von-Guericke Universität Magdeburg — Magdeburg, Germany (enrolling)
• Hamburg UKE Abt. Neuropädiatrie — Hamburg, Germany
• Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour — Nijmegen, Netherlands
• Department of Neurology, Medical University, Innsbruck — Innsbruck, Austria
• Universita cattolica del sacro cuore — Rome, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.