ALS/MND Natural History Study Data Repository

NCT05966038 · tracked via the Priya Life Science Italy tracker

Sponsor

Massachusetts General Hospital

Phase

Observational

Started

2015-04-01

Last updated

2026-05-20

Condition(s) studied

ALSPLSMND (Motor Neurone DIsease)Kennedy DiseasePMA - Progressive Muscular AtrophyPBP - Progressive Bulbar Palsy

Study summary

This is a data repository for multi-site multi-protocol clinic-based Natural History Study of ALS and Other Motor Neuron Disorders (MND).

All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites) are offered to participate in the Study.

The Sites collect so-called Baseline information including demographics, disease history and diagnosis, family history, etc. At each visit, the Sites also collect multiple disease-specific outcome measures and events. The information is captured in NeuroBANK, a patient-centric clinical research platform.

The Sites have an option to choose to collect data into 20+ additional forms capturing biomarkers and outcome measures. Captured data after its curation are anonymized (all personal identifiers and dates are being removed), and the anonymized dataset is shared with medical researchers via a non-exclusive revocable license.

Funding Source - Biogen, Inc.; Mitsubishi Tanabe Pharma America; FDA OOPD.

Eligibility

Sex

ALL

Min age

18 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: * A clinical diagnosis of El Escorial of suspected, possible, probable, or definite ALS or * Other motor neuron disorders, including but not limited to Spinal-Bulbar Muscular Atrophy (SBMA, Kennedy's disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP) Exclusion Criteria: * Disease does not meet criteria for any motor neuron disorder

Primary outcome measure(s)

ALS Functional Rating Scale-Revised (ALSFRS-R) — Every 3-4 months up to 5 years
The ALS Functional Rating Scale revised is a 12-item rating scale that measures the progression of disability in patients with ALS. The ALSFRS-r assesses patients' levels of self-sufficiency in areas of feeding, grooming, ambulation and communication. The higher the score, the earlier in the disease progression. It consists of 12 questions with a maximum score of 48 points.
Slow Vital Capacity (SVC) — Every 3-4 months up to 5 years
Slow vital capacity test normalized to age, sex, and height
Survival — Every 3-4 months up to 5 years
Patient survival or survival equivalent (time to ventilator or feeding tube). Survival equivalent is assessed during routine clinical visits, while mortality event may be reported when becomes known to the treating clinician..

Trial sites (18)

Facility	City	Region	Status
Loma Linda University Health	Loma Linda	California	Recruiting
Kaiser Permanente	Los Angeles	California	Recruiting
University of Florida	Gainesville	Florida	Recruiting
Northwestern University	Chicago	Illinois	Recruiting
Lahey Clinic	Burlington	Massachusetts	Recruiting
Henry Ford Health System	Detroit	Michigan	Recruiting
Trinity Health Michigan	Grand Rapids	Michigan	Recruiting
University of Minnesota	Minneapolis	Minnesota	Recruiting
Saint Louis University	St Louis	Missouri	Recruiting
Providence ALS Clinic	Portland	Oregon	Recruiting
Thomas Jefferson University	Philadelphia	Pennsylvania	Recruiting
Temple University Lewis Katz School of Medicine	Philadelphia	Pennsylvania	Recruiting
University of Pittsburgh	Pittsburgh	Pennsylvania	Recruiting
Virginia Commonwealth University	Richmond	Virginia	Recruiting
Hadassah Medical Organization	Jerusalem	Israel	Recruiting
Tel Aviv Medical Center	Tel Aviv	Israel	Recruiting
Centro Clinico NEMO Milano	Milan	Italy	Recruiting
Istituti Clinici Scientifici Maugeri SpA	Milan	Italy	Recruiting

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Other trials for the same condition

At-home Treatment With Cortico-spinal tDCS for Amyotrophic Lateral Sclerosis Recruiting

Genetics and Environment iNtersection In the ALS-FTD Spectrum: an Italian Twins Cohort studY With a Multi-Omics Approach Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05966038 on ClinicalTrials.gov ↗ ← All trials in Italy