Not a traditional drug phase: Sudoscan testing for Sjögren's Syndrome
The investigators propose to conduct a prospective study evaluating the prevalence of SNN in pSS patients and to find clinical characteristics and specific immunological profiles in pSS patients with SFN. Peripheral nervous system involvement account for 15% of pSS cases.
Official registry: https://clinicaltrials.gov/study/NCT07917442 · Centre Hospitalier Universitaire, Amiens · enrollment listed as 100
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Sudoscan testing. The registry lists allocation as na. The investigators propose to conduct a prospective study evaluating the prevalence of SNN in pSS patients and to find clinical characteristics and specific immunological profiles in pSS patients with SFN.
They plan to enroll about 100 people at Amiens. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome
Interventions: Sudoscan testing
Primary outcome (registry wording): prevalence of SFN in patients with pSS
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Primary Sjögren's syndrome confirmed according to ACR/EULAR criteria 2016
- Body Mass Index between 18 and 35 kg/m²
Who the registry excludes
- Secondary or unconfirmed Sjögren's syndrome,
- Age \< 18 years, Use of medications that could interfere with Sudoscan results and which could not be discontinued before inclusion,
- Other conditions that may cause small fiber neuropathy,
- excessive alcohol consumption,
Public study contact (from the registry)
Valéry SALLE, MD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- CHU Amiens — Amiens, France (recruiting)
FAQ about this NCT record
Is NCT07917442 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07917442?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07917442?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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