Creation of a Clinical Database for the Study of Phenotyp... | NCT06318585

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

NCT06318585

Sponsor

Istituto Auxologico Italiano

Status

Recruiting

Last Update Posted

May 7, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Amyotrophic Lateral Sclerosis
Motor Neuron Disease

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2023Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 8, 2024

First Submission Date that Met QC Criteria

Mar 15, 2024

First Posted Date

Mar 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2025

Last Update Posted Date

May 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of ALS or other motor neuron disease

Exclusion Criteria:

refusal to participate to the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive cohort of patients from a tertiary Italian ALS Centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nicola Ticozzi, MD, PhD	Contact	+390261911	2937	n.ticozzi@auxologico.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale San Luca	Recruiting	Milan	MI	20149	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis
D016472	Motor Neuron Disease

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases

Browse Leaves

Not provided

Browse Branches

Not provided