Natural history of sporadic degenerative ataxia in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the clinical features and progression rates of multiple system atrophy of cerebellar type (MSA-C) and sporadic adult onset ataxia of unknown aetiology (SAOA) in adults who develop ataxia after the age of 40. It will also investigate factors that may predict the development of MSA-C versus SAOA and determine when a reliable distinction between these disorders can be made. Additionally, blood samples and other biomaterials will be collected for future genetic and biomarker studies. The study will create a European registry for patients with sporadic degenerative ataxia to enhance understanding of these conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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's running

• Universitätsmedizin Berlin Charité
  Berlin, Germany Recruiting
• Department of Neurology, University of Bonn
  Bonn, Germany Recruiting
• Department of Neurology, University Clinic Essen, University of Duisburg-Essen
  Essen, Germany Recruiting
• Department of Neurology, University of Frankfurt
  Frankfurt, Germany Recruiting
• Otto-von-Guericke Universität Magdeburg
  Magdeburg, Germany Recruiting
• Friedrich-Baur-Institut an der Neurologischen Klinik
  München, Germany Recruiting

Study contacts

• Principal investigator: Thomas Klockgether, MD — Department of Neurology, Bonn, Germany
• Study coordinator: Ilaria Anna Giordano, MD
• Email: ilaria_anna.giordano@ukb.uni-bonn.de
• Phone: 0049 228 287 15750

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.