ClinicalTrials.gov record NCT02701036

Sporadic Degenerative Ataxia With Adult Onset: Natural History Study

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 7, 2026

Sporadic Degenerative Ataxia With Adult Onset: Natural History Study (SPORTAX-NHS)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jun 29, 2017, about 9 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age40 years old and older
SexAll
LocationAustria, Germany, Italy, Netherlands, Norway
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective observational study follows adults with late-onset sporadic cerebellar ataxia (after exclusion of acquired and known genetic causes) to compare two forms: multiple system atrophy of cerebellar type (MSA-C) and sporadic adult-onset ataxia of unknown etiology (SAOA). Participants undergo regular (typically yearly) clinical assessments and may give blood and other biomaterials for genetic and biomarker studies. The study aims to define how quickly each condition progresses and which factors predict conversion from SAOA to MSA-C.

What it is studying. Whether and how the clinical features and progression rate differ between MSA-C and SAOA, which factors predict development of MSA-C versus SAOA, and when a reliable distinction between the two becomes possible; the study also collects blood and other biomaterials for future genetic and biomarker research.

What the researchers hope to learn. To map the natural history of late-onset sporadic cerebellar ataxias; to compare clinical features of MSA-C and SAOA; to measure and compare progression rates; to identify clinical or other factors that predict who develops MSA-C versus who remains classified as SAOA; and to build a biosample collection for future genetic and biomarker studies.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Progressive ataxia frequently starts in adults without a familial background. These patients may suffer from an acquired ataxia or a genetically determined ataxia despite negative family history. In the majority of them, however, a genetic or acquired cause of ataxia cannot be identified suggesting a sporadic degenerative ataxia. They can be subdivided into two groups. In one group, the underlying brain disease is multiple system atrophy (MSA), specifically MSA of cerebellar type (MSA-C). The characteristic clinical feature of MSA is the presence of severe autonomic failure defined by orthostatic hypotension or urinary incontinence. The second group is distinguished from MSA-C by the lasting absence of severe autonomic failure. These patients have been designated as sporadic adult onset ataxia of unknown aetiology (SAOA). In the first years after ataxia onset, a distinction between MSA-C and SAOA is often not possible. There are only few studies comparing the phenotype of MSA-C and SAOA, and longitudinal studies focussing on the evolution of the phenotype of these disorders are completely lacking. In particular, the progression rate of SAOA compared to MSA-C has not been defined. In addition, it is unknown which factors predict the development of MSA-C vs. SAOA, and at which time after onset of ataxia, a reliable distinction between both disorders is possible. To answer these questions, we plan to create a European registry of patients with sporadic degenerative ataxia of adult onset and to perform a natural history study. 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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants have yearly clinical visits with neurological exams and standardized ataxia ratings. Assessments include objective timed tests (8‑m walk, 9‑hole peg test, timed speech task), scales for non‑ataxia and MSA features, and questionnaires about quality of life, mood, and REM‑behavior symptoms. Blood and other biomaterials will be collected for future genetic and biomarker research. Follow‑up is long‑term with yearly assessments over multiple years.

How the study is structured. A prospective observational cohort: people with late-onset sporadic degenerative ataxia are followed over many years with regular clinic visits. At visits clinicians use standardized ataxia and symptom scales (for example SARA and UMSARS), record non-ataxia signs and quality-of-life and mood questionnaires, and collect blood and other biosamples for storage and later analysis.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Late Onset Sporadic Cerebellar Ataxia. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Austria, Germany, Italy, Netherlands, Norway. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on multiple system atrophy

Clinical trials76 trials listed for multiple system atrophyEvery trial the registry lists for multiple system atrophy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in multiple system atrophy researchLatest monthly update: September 2026. Includes: Tube feeding. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
April 2010
Primary completion
December 2030 (estimated)
Study completion
December 2030 (estimated)
Target enrollment
300 participants (estimated)
Last updated on registry
Jun 29, 2017
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Ataxia Study Group
Principal investigator
Prof. Dr. Thomas Klockgether, Prof. Dr. Thomas Klockgether
Ataxia Study Group
Collaborators
  • German Center for Neurodegenerative Diseases (DZNE)

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (14)

Terms used on this page · explanations by MedicalUpdates.ai

biomarker
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
registry
An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
natural history study
A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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