Amyotrophic Lateral SclerosisALS-PHENONCT06318585
Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Study Description: Characterization of Motor Neuron Disease Phenotypes The goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive cohort of patients from a tertiary Italian ALS Centre
Who may be able to join
- diagnosis of ALS or other motor neuron disease
Who cannot join
- refusal to participate to the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Luca
Milan, MI, 20149
Alberto Doretti, MD, +0261911 ext. 2937, a.doretti@auxologico.it
About this study
Official title: Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone
Study Description: Characterization of Motor Neuron Disease Phenotypes
The goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:
Read more
- What are the specific clinical phenotypes associated with MND?
- How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?
Participants will undergo:
- Clinical evaluation using validated scales
- Neurophysiological and neuroradiological instrumental assessment
- Neuropsychological evaluation
- Collection of biological materials for genetic screening and biomarker assessment, if necessary.
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
no. of patients with classic ALS
no. of patients with classic ALS
Measured: baseline (at diagnosis), at 1 year
no. of patients with bulbar ALS
no. of patients with bulbar ALS
Measured: baseline (at diagnosis), at 1 year
no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
Measured: baseline (at diagnosis), at 1 year
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
Measured: baseline (at diagnosis), at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start3 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318585
- Sponsor's protocol ID
- 23C306
- Acronym
- ALS-PHENO
- Status last verified
- May 2025
- First submitted
- 8 Mar 2024
- Last updated
- 7 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone
- ClinicalTrials.gov ID
- NCT06318585
- Acronym / sponsor ID
- ALS-PHENO / 23C306
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Description: Characterization of Motor Neuron Disease Phenotypes
The goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:
- What are the specific clinical phenotypes associated with MND?
- How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?
Participants will undergo:
- Clinical evaluation using validated scales
- Neurophysiological and neuroradiological instrumental assessment
- Neuropsychological evaluation
- Collection of biological materials for genetic screening and biomarker assessment, if necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive cohort of patients from a tertiary Italian ALS Centre
Key inclusion criteria (1 listed)
- diagnosis of ALS or other motor neuron disease
Key exclusion criteria (1 listed)
- refusal to participate to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
no. of patients with classic ALS
Time frame: baseline (at diagnosis), at 1 year
no. of patients with classic ALS
no. of patients with bulbar ALS
Time frame: baseline (at diagnosis), at 1 year
no. of patients with bulbar ALS
no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
Time frame: baseline (at diagnosis), at 1 year
no. of patients with LMN phenotypes (flail arm, flail leg, PMA)
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
Time frame: baseline (at diagnosis), at 1 year
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Motor Neuron Disease, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Ticozzi, MD, PhD (+390261911 ext. 2937, n.ticozzi@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no. of patients with classic ALS (time frame: baseline (at diagnosis), at 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.