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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 2 sites (Telese Terme, Benevento and 1 other locations) |
| Status | Recruiting |
| Started | May 15, 2021 |
| Main results expected | September 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT05747937 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
- Principal investigator: Maria Nolano, MD, PhD — Istituti Clinici Scientifici Maugeri SpA
- Study coordinator: Maria Nolano, MD, PhD
- Email: maria.nolano@icsmaugeri.it
- Phone: +390824909257
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.