UnknownNot Applicable

Astrocytic Markers and the Pre-ataxic Period of SCA3/MJD - BIGPRO Study Astrocytes

Brazil95 participantsStarted 2017-03-18

Plain-language summary

The study will consist of a prospective observation of subjects in a natural history design. The investigators will monitor changes of clinical scales, quality of life, messenger ribonucleic acid (mRNA) of candidate genes (CCL11, TNFSF14, FCGR3B, CLC, and SLA) (and their peptide products, when possible), and eotaxin and S100B serum levels, in order to determine which of them is (are) the most sensitive. Participants will be stratified in three groups: ataxic carriers, pre-ataxic carriers and non-carriers (controls).

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Individuals with molecular diagnosis of SCA3/MJD * Individuals at 50% risk of inheriting SCA3/MJD mutation without any clinical manifestation Exclusion Criteria: * Refusal to sign informed consent * Other diagnosed neurological conditions; * Diabetes Mellitus; * Chronic allergy (asthma, eczema, urticaria) * Eosinophilia on baseline

What they're measuring

Change in serum concentrations of Eotaxin

Timeframe: 24 months

Change in serum concentrations of S100B

Timeframe: 24 months

Change in expression of TNFSF14

Timeframe: 24 months

Change in expression of CCL11

Timeframe: 24 months

Change in EQ-5D-3L (EuroQoL 5 Domains evaluated in 3 levels)

Timeframe: 24 months

Change in SF-36 (Short-form 36)

Timeframe: 24 months

Trial details

NCT IDNCT04419974

SponsorHospital de Clinicas de Porto Alegre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Spinocerebellar Ataxia Type 3 trials