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Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases (ALS-PHENO)

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ClinicalTrials.gov Identifier: NCT06318585
Recruitment Status : Recruiting
First Posted : March 19, 2024
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Tracking Information
First Submitted Date March 8, 2024
First Posted Date March 19, 2024
Last Update Posted Date March 19, 2024
Actual Study Start Date April 3, 2023
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2024)
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases
Official Title Creazione di un Database Clinico Per lo Studio Della variabilità Fenotipica Nella Malattia Del Motoneurone
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, plasma, serum, CSF
Sampling Method Non-Probability Sample
Study Population Consecutive cohort of patients from a tertiary Italian ALS Centre
Condition
  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 15, 2024)		 200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2026
Estimated Primary Completion Date December 31, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosis of ALS or other motor neuron disease

Exclusion Criteria:

  • refusal to participate to the study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Nicola Ticozzi, MD, PhD +390261911 ext 2937 n.ticozzi@auxologico.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT06318585
Other Study ID Numbers 23C306
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Istituto Auxologico Italiano
Original Responsible Party Same as current
Current Study Sponsor Istituto Auxologico Italiano
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Istituto Auxologico Italiano
Verification Date March 2024