Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases
ALS-PHENO
Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone
1 other identifier
observational
200
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 2023
CompletedFirst Submitted
Initial submission to the registry
March 8, 2024
CompletedFirst Posted
Study publicly available on registry
March 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 7, 2025
May 1, 2025
3.7 years
March 8, 2024
May 5, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
no. of patients with classic ALS
no. of patients with classic ALS
baseline (at diagnosis), at 1 year
no. of patients with bulbar ALS
no. of patients with bulbar ALS
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)
baseline (at diagnosis), at 1 year
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
no. of patients with UMN phenotypes (pyramidal ALS, PLS)
baseline (at diagnosis), at 1 year
Eligibility Criteria
Consecutive cohort of patients from a tertiary Italian ALS Centre
You may qualify if:
- diagnosis of ALS or other motor neuron disease
You may not qualify if:
- refusal to participate to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale San Luca
Milan, MI, 20149, Italy
Biospecimen
DNA, plasma, serum, CSF
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2024
First Posted
March 19, 2024
Study Start
April 3, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 7, 2025
Record last verified: 2025-05