Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases

Amyotrophic Lateral Sclerosis Clinical Trial

— ALS-PHENO  

Official title:

Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318585
• Other study ID #: 23C306
• Status: Recruiting
• Start date: April 3, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Nicola Ticozzi, MD, PhD
• Phone: +390261911
• Email: n.ticozzi[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of ALS or other motor neuron disease

Exclusion Criteria:

• refusal to participate to the study

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Locations

Country	Name	City	State
Italy	Ospedale San Luca	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	no. of patients with classic ALS	no. of patients with classic ALS	baseline (at diagnosis), at 1 year
Primary	no. of patients with bulbar ALS	no. of patients with bulbar ALS	baseline (at diagnosis), at 1 year
Primary	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
Primary	no. of patients with UMN phenotypes (pyramidal ALS, PLS)	no. of patients with UMN phenotypes (pyramidal ALS, PLS)	baseline (at diagnosis), at 1 year