The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4

ConditionsHereditary Spastic Paraplegia Hereditary, Spastic Paraplegia, Autosomal Dominant

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorUniversity Hospital Tuebingen

About this trial

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

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

SPRS Score and clinical signs
Cognition Testing using CANTAB
Lumbar Puncture and blood draw
MRI
Electrophysiology
Testing functional performance
Non motor symptoms

Treatment groups

200 Participants

are divided into 3 treatment groups

Sponsors and collaborators

University Hospital Tuebingen

Lead sponsor

Source ClinicalTrials.gov