Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Evaluating the Nervous System in ALS Patients

Official title: Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Run by Istituti Clinici Scientifici Maugeri SpA · NCT05747937 · Data updated 2026-11-12

This study is testing if skin samples can help track how the nervous system is affected in people with ALS over 18 months after their symptoms start.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorIstituti Clinici Scientifici Maugeri SpA
Academic / other
Locations2 sites (Telese Terme, Benevento and 1 other locations)
StatusRecruiting
StartedMay 15, 2021
Main results expectedSeptember 30, 2026
Study endsDecember 30, 2026
Registry record updatedApril 17, 2026
Trial IDNCT05747937 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are ALS patients who are within 18 months of experiencing motor symptoms.

Probably not a fit

Patients with glucose intolerance or other conditions affecting the peripheral nervous system may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to assess the progression of autonomic and sensory nervous system involvement in patients with amyotrophic lateral sclerosis (ALS) within 18 months of motor symptom onset. It employs a multimodal approach, including skin biopsies and various clinical assessments, to explore the relationship between autonomic dysfunction and overall disease progression. The study seeks to identify biomarkers in the skin that could serve as reliable measures for tracking disease progression and response to future treatments.

Why it matters

Potential benefit: If successful, this study could lead to improved methods for monitoring ALS progression and tailoring treatments for patients.

How similar studies have gone: While the specific approach of this study may be novel, similar studies have shown promise in understanding ALS progression through biomarker identification.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* ALS patients will be recruited within 18 months from the motor symptoms onset

Exclusion Criteria:

* glucose intolerance or conditions potentially affecting the peripheral nervous system

Where it's running

  • ICS Maugeri - IRCCS of Telese Terme
    Telese Terme, Benevento, Italy
    Recruiting
  • Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II
    Naples, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Repeated ultrasound-assisted blood-brain barrier opening in ALS

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.