RecruitingNCT06572046

STOP-HSP.Net: a Registry for Hereditary Spastic Paraplegia as an Integration Tool for Future Therapeutic Strategies


Sponsor

IRCCS Fondazione Stella Maris

Enrollment

500 participants

Start Date

Jan 24, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Our goal is to create a solid and harmonious disease registry of patient affected by hereditary spastic paraplegia (HSP) that facilitates the collection and management of patients' data over time encouraging the research and the development of future clinical trials. In-depth clinical phenotyping will develop significant clinical outcome measures that can be used in clinical trials and will allow the phenotypic complexity of the disease to be captured with the use of validated clinical scales, biomarkers and so-called patient reported outcomes (PROs).


Eligibility

Inclusion Criteria2

  • clinical diagnosis of pure or complex HSP/spastic ataxia, even in the absence of a known genetic diagnosis
  • participants/parents/legal guardians will have to give informed consent for enrollment in the registry and privacy data management

Exclusion Criteria3

  • subjects affected by secondary forms of HSP
  • presenting comorbidities that affect the general clinical picture according to clinical judgment
  • lack of informed consent

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Locations(1)

IRCCS Fondazione Stella Maris

Pisa, Italy

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NCT06572046


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