NCT06572046 STOP-HSP.Net: a Registry for Hereditary Spastic Paraplegia as an Integration Tool for Future Therapeutic Strategies
| NCT ID | NCT06572046 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Fondazione Stella Maris |
| Condition | Hereditary Spastic Paraplegia |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-01-24 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-01-24 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * subjects affected by secondary forms of HSP * presenting comorbidities that affect the general clinical picture according to clinical judgment * lack of informed consent
Contact & Investigator
Filippo M Santorelli, Dr.
PRINCIPAL INVESTIGATOR
IRCCS Fondazione Stella Maris
Frequently Asked Questions
Who can join the NCT06572046 clinical trial?
This trial is open to participants of all sexes, studying Hereditary Spastic Paraplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06572046 currently recruiting?
Yes, NCT06572046 is actively recruiting participants. Contact the research team at filippo.santorelli@fsm.unipi.it for enrollment information.
Where is the NCT06572046 trial being conducted?
This trial is being conducted at Pisa, Italy.
Who is sponsoring the NCT06572046 clinical trial?
NCT06572046 is sponsored by IRCCS Fondazione Stella Maris. The principal investigator is Filippo M Santorelli, Dr. at IRCCS Fondazione Stella Maris. The trial plans to enroll 500 participants.