Actively Recruiting

Age: 40Years +
All Genders
Healthy Volunteers
NCT02701036

Sporadic Degenerative Ataxia With Adult Onset: Natural History Study

Led by Ataxia Study Group · Updated on 2017-06-29

300

Participants Needed

14

Research Sites

1078 weeks

Total Duration

On this page

Sponsors

A

Ataxia Study Group

Lead Sponsor

G

German Center for Neurodegenerative Diseases (DZNE)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Sporadic Degenerative Ataxia With Adult Onset: Natural History Study

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • No established acquired cause of ataxia
  • 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
  • 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
  • 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 thyroid function

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Department of Neurology, Medical University, Innsbruck

Innsbruck, Austria

Active, Not Recruiting

2

Universitätsmedizin Berlin Charité

Berlin, Germany

Actively Recruiting

3

Department of Neurology, University of Bonn

Bonn, Germany, 53105

Actively Recruiting

4

Department of Neurology, University Clinic Essen, University of Duisburg-Essen

Essen, Germany

Actively Recruiting

5

Department of Neurology, University of Frankfurt

Frankfurt, Germany

Actively Recruiting

6

Hamburg UKE Abt. Neuropädiatrie

Hamburg, Germany

Active, Not Recruiting

7

Otto-von-Guericke Universität Magdeburg

Magdeburg, Germany

Actively Recruiting

8

Friedrich-Baur-Institut an der Neurologischen Klinik

München, Germany

Actively Recruiting

9

Universitätsmedidzin Rostock - Klinik und Poliklinik für Neurologie

Rostock, Germany

Actively Recruiting

10

Dept. of Neurodegenerative Diseases Tübingen

Tübingen, Germany

Actively Recruiting

11

Department of Neuroscience, Federico II University Naples

Naples, Italy

Actively Recruiting

12

Universita cattolica del sacro cuore

Rome, Italy

Active, Not Recruiting

13

Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour

Nijmegen, Netherlands

Active, Not Recruiting

14

Oslo University Hospital

Oslo, Norway

Actively Recruiting

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Research Team

I

Ilaria Anna Giordano, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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