An observational study in Amyotrophic Lateral Sclerosis and Motor Neuron Disease, sponsored by Istituto Auxologico Italiano. Recruiting at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Istituto Auxologico Italiano · Observational
Among 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy — 27 open to participants now, 36 under way, 7 of them phase 3. Amyotrophic Lateral Sclerosis · Italy.
Among the 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy, this one is the 10th largest by planned enrollment of the 20 observational ones that give a count, is one of 6 that started in 2023, is one of 20 observational ones, reaches primary completion later than 6 of the 35 other live ones, and was the 62nd registered.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →27 of the 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy are open now. Recruiting first, the newest first:
Leal Therapeutics, Inc · Sites in Italy, Germany, Netherlands and 1 more country
Ages 18–75
Prilenia · Sites in Italy, United States, Belgium and 10 more countries
Ages 18–80
Istituto Auxologico Italiano · Sites in Italy
Ages 18+
Zydus Therapeutics Inc. · Sites in Italy, United States, Australia and 9 more countries
Ages 18+
University of Trieste · Sites in Italy
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 192 Amyotrophic Lateral Sclerosis studies recruiting now, 117 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
89 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 26 · Phase 3 24 · Phase 4 2
First in 2003; this study’s year is marked. 6 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.
Median enrollment 87 across the 69 interventional studies, 200 across the 20 observational. Of the 46 that completed or were terminated, 23 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 89 have an industry lead sponsor. The 10 most frequent:
Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
Istituto Auxologico Italiano has 7 studies filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
11 of the studies in Amyotrophic Lateral Sclerosis with a site in Italy that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06126315Phase 3Mario Negri Institute for Pharmacological ResearchTrial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS | 2027-04 |
| NCT04856982Phase 3BiogenStudy to Learn If Tofersen (BIIB067) Can Delay ALS Symptoms and About Its Safety in Adults With a SOD1 Gene Mutation Who Have Not Yet Developed ALS Symptoms | 2027-08-07 |
| NCT06881979Istituti Clinici Scientifici Maugeri SpAHigh-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases - Fit4MedRob-Chronic MND Project | 2026-11 |
| NCT07616050Marta MondelliniEvaluation of the Impact of Virtual Park on Training Motivation in Adult Patients | 2026-12 |
| NCT06318585Istituto Auxologico ItalianoCreation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases | 2026-12-31 |
Add all 11 to your calendar (.ics) → With an account.
Among the 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:
Participants will undergo:
Consecutive cohort of incident patients from three Italian ALS Centers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
genetic screening
no. of patients with ALS-associated mutations
Time frame: baseline (at diagnosis)
biomarker assessment
no. of patients with abnormal NfL, GFAP, tau, UCHL1, MCP1 and TDP-43 levels
Time frame: baseline (at diagnosis), at 6 months, at 1 year
clinical assessment
no. of patients with increasing vs decreasing PUMNS/LMNS scores
Time frame: baseline (at diagnosis), at 6 months, at 1 year
neuropsychological assessment
no. of patients with increasing vs decreasing ECAS scores
Time frame: baseline (at diagnosis), at 1 year
Started Apr 2023 (actual). Primary completion is estimated for Apr 2026, 35 months after the start.
Of 127 non-industry observational studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 125. This study's planned 35 months is below that.
Counting every sponsor, half of 136 studies reached it within 64 months; a quarter within 29 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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