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NCT05747937
Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS
NA trial testing Skin biopsy in Amyotrophic Lateral Sclerosis in 100 participants. Currently enrolling.
30 September 2026
Quick facts
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 100 |
| Start date | 15 May 2021 |
| Primary completion | 30 September 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Skin biopsy
- Cardiovascular Reflexes testing
- Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms
- Dinamic Sweat Test
Conditions studied
- Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Who can join
18 and older, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this interventional non-pharmacological study is to evaluate, using a multimodal approach, the progression of autonomic and sensory involvement in in amyotrophic lateral sclerosis (ALS) patients enrolled within 18 months from motor onset and its relationship with the progression of overall clinical disability. The main questions it aims to answer are: * Is autonomic dysfunction at diagnosis associated with disease progression and survival in patients with Amyotrophic Lateral Sclerosis ? * Can we identify in the skin biomarkers to be used as reliable measures of disease progression and to apply in future clinical trials for patient stratification and to assess response to drug treatment ? Participants at time 0 will receive a full clinical and instrumental examination and a blood sample testing to check inclusion and exclusion criteria, genetic screening for the most common genes associated with ALS (SOD1, FUS, TARDBP and c9orf72), questionnaires about clinical characteristics, quality of life, pain and a multidomain battery of neuropsychological tests, multimodal assessment of the autonomic nervous system including skin biopsy for morphological study. At follow-up we'll perform clinical scales and skin biopsy. Researchers will compare results from ALS patients with data obtained from a population of age and sex matched healthy subjects.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Neurophysiologic Innovations in ALS: Enhancing Diagnosis, Monitoring, and Treatment Evaluation.
Donaghy R, Pioro EP. · · 2024 · cited 2× · PMID 39766450 · DOI 10.3390/brainsci14121251
Verify or expand the search:
- PubMed search for NCT05747937
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05747937 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituti Clinici Scientifici Maugeri SpA
- Last refreshed: 17 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05747937.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing