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Taking people in ItalyNo phase

Sporadic Degenerative Ataxia With Adult Onset: Natural History Study

Key facts

Who runs it
Ataxia Study Group
Where
Naples and Rome, ItalySee the 2 sitesAlso in 4 other countries, 12 sites
Trial code
Status
Recruiting
People taking part
300 people, planned
Started
Apr 2010
Expected to end
Dec 2030
Type of study
Observational, 2 groups
Record updated
29 June 2017

Who can take part

Age
40 years and older
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

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Who can take part

  • 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)

Who cannot take part

  • no chronic intake of anticonvulsant drugs
  • No onset of ataxia in association with stroke, encephalitis, sepsis, hyperthermia or heat stroke
  • no other toxic causes; no malignancies
  • no insulin-dependent diabetes mellitus; Imaging exclusion criteria:
  • No evidence of multiple sclerosis, ischemia, hemorrhage or tumor of the posterior fossa
  • 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)
  • absence of signal abnormalities on T2/FLAIR-images except abnormalities compatible with MSA; Laboratory exclusion criteria:
  • No established acquired cause of ataxia; Clinical exclusion criteria:
  • no chronic diarrhea
  • no unexplained visual loss
  • no alcohol abuse
  • no rapid progression (development of severe ataxia in less than 12 weeks)
  • normal levels of vitamin B12
  • VDRL negative
  • normal thyreoid function

Where in Italy

Also in 4 other countries, 12 sites

  • Department of Neuroscience, Federico II University NaplesNaples, ItalyContact: Alessandro Filla, MDTaking people
  • Università Cattolica del Sacro CuoreRome, ItalyContact: Ilaria Anna Giordano, MDNo longer taking part

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • sporadic adult onset ataxia

    SAOA denotes the non-hereditary degenerative adult-onset ataxia disorders that are distinct from multiple system atrophy (MSA). SAOA is a group of ataxia of unknown etiology characterized by a slowly progressive cerebellar syndrome starting around the age of 50 years. Possibly is accompanied by signs of mild autonomic dysfunction that do not meet the criteria of severe autonomic failure required for a diagnosis of MSA.

  • cerebellar multiple system atrophy

    Multiple system atrophy of cerebellar type is a cerebellar syndrome with sporadic onset developing in midlife, with autonomic features of otherwise unexplained bladder dysfunction with or without erectile dysfunction in males, orthostatic hypotension and atrophy of the cerebellum, brainstem, and middle cerebellar peduncles.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Sporadic Degenerative Ataxia With Adult Onset: Natural History Study (SPORTAX-NHS)
Record updated
29 June 2017