NCT03206190 The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4
| NCT ID | NCT03206190 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Tuebingen |
| Condition | Hereditary Spastic Paraplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2018-07-01 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2018-07-01 with a primary completion date of 2029-12.
⚠ 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
Study goals 1. Prospective longitudinal data on progression in the natural course of SPG4 in presymptomatic mutation carriers prior to clinical disease onset and in early stages of disease 2. Biomarkers providing objective measures of disease activity
Eligibility Criteria
Inclusion Criteria: * First degree relatives (parents, offspring, and sibs) of SPG4 patients or symptomatic individuals with known SPAST mutation * Age 18 to 70 years * Written, informed consent (patient) Exclusion Criteria: * No known SPAST-mutation within the family * Manifest spastic gait (subclinical signs like increased deep tendon reflexes, positive Babinski sign are allowed) * Participation in interventional trials
Contact & Investigator
Ludger Schöls, Prof.
PRINCIPAL INVESTIGATOR
Head of Department
Frequently Asked Questions
Who can join the NCT03206190 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, 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 NCT03206190 currently recruiting?
Yes, NCT03206190 is actively recruiting participants. Contact the research team at ludger.schoels@uni-tuebingen.de for enrollment information.
Where is the NCT03206190 trial being conducted?
This trial is being conducted at Tübingen, Germany.
Who is sponsoring the NCT03206190 clinical trial?
NCT03206190 is sponsored by University Hospital Tuebingen. The principal investigator is Ludger Schöls, Prof. at Head of Department. The trial plans to enroll 200 participants.