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Clinical Trial NCT05966038 for ALS, PLS, MND (Motor Neurone DIsease), Kennedy Disease, PMA - Progressive Muscular Atrophy, PBP - Progressive Bulbar Palsy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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ALS/MND Natural History Study Data Repository 5,000 Biomarker-Driven
Clinical Trial NCT05966038 is an observational study for ALS, PLS, MND (Motor Neurone DIsease), Kennedy Disease, PMA - Progressive Muscular Atrophy, PBP - Progressive Bulbar Palsy that is recruiting. It started on April 1, 2015 with plans to enroll 5,000 participants. Led by Massachusetts General Hospital, it is expected to complete by December 31, 2030. The latest data from ClinicalTrials.gov was last updated on November 14, 2025.
Brief 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 Site...
Show MoreDetailed Description
Most people with ALS or MND who are seen clinically by the PI or PI designees at participating sites will be recruited into this study. This well-established framework provides an opportunity to offer to a large proportion of people with ALS/MND a chance to participate in a clinical research project.
Upon obtaining consent, the following is done:
People with ALS/MND are assigned a Neurological Global Unique Identif...
Show MoreOfficial Title
ALS/MND Natural History Study Data Repository
Conditions
ALSPLSMND (Motor Neurone DIsease)Kennedy DiseasePMA - Progressive Muscular AtrophyPBP - Progressive Bulbar PalsyOther Study IDs
- 2013P001670
- 5U01FD008125-02 (U.S. FDA Grant/Contract)
- 2022A011556 (Other Grant/Funding Number) (Biogen, Inc.)
- 2022A018800 (Other Grant/Funding Number) (Mitsubishi Tanabe Pharma America)
NCT ID Number
Start Date (Actual)
2015-04-01
Last Update Posted
2025-11-14
Completion Date (Estimated)
2030-12-31
Enrollment (Estimated)
5,000
Study Type
Observational
Status
Recruiting
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
ALS Functional Rating Scale-Revised (ALSFRS-R) | 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. | Every 3-4 months up to 5 years |
Slow Vital Capacity (SVC) | Slow vital capacity test normalized to age, sex, and height | Every 3-4 months up to 5 years |
Survival | 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.. | Every 3-4 months up to 5 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Vital Signs | Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured. | Every 3-4 months up to 5 years |
Neurological Examination | Neurological exam that tests for abnormality various areas, from general assessment to coordination and cerebellar function, to sensation and reflexes, to cranial nerves and plantar | Through study completion, annually up to 5 years |
El Escorial Criteria | The El Escorial criteria are diagnostic criteria for ALS. They classify patients into categories of possible, probable, or definite ALS, based on signs of degeneration of upper and lower motor neurons in different body regions. | Through study completion, annually up to 5 years |
Handheld Dynamometry | Handheld Dynamometry for quantitative strength testing of 18 muscles that is a reliable and reproducible measure of decline in ALS | Every 3-4 months up to 5 years |
Grip Strength Testing | Grip Strength Testing | Every 3-4 months up to 5 years |
Rasch Overall ALS Disability Scale (ROADS) | Rasch Overall ALS Disability Scale, the ROADS provides a normed total score on 28 items from 0-146 to capture overall disability level in a linearly-weighted manner, with lower scores indicating disease progression | Every 3-4 months up to 5 years |
5 Times Sit to Stand | 5 Times Sit to Stand Test | Every 3-4 months up to 5 years |
10 Meter Walk Test | 10 Meter Walk Test | Every 3-4 months up to 5 years |
Physical Examination | Physical Examination that includes the following test areas for abnormality and clinical significance: respiratory, cardio, gastrointestinal, genitourinary. and musculoskeletal | Through study completion, annually up to 5 years |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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)
- Disease does not meet criteria for any motor neuron disorder
Massachusetts General Hospital- ⚕️Henry ...
Study Responsible Party
Alexander Sherman, Principal Investigator, Director, Center for Innovation and Bioinformatics, Massachusetts General Hospital
Study Central Contact
Contact: Natalia Tarasenko, 1617240346, [email protected]
16 Study Locations in 3 Countries
California
Loma Linda University Health, Loma Linda, California, 92354, United States
Jeffrey Rosenfeld, MD, Principal Investigator
Recruiting
Kaiser Permanente, Los Angeles, California, 90027, United States
Chris Greer, Contact, 323-783-9284, [email protected]
Abel Wu, MD, Principal Investigator
Recruiting
Florida
University of Florida, Gainesville, Florida, 32610, United States
Jennifer Steshyn, Contact, [email protected]
James Wymer, Principal Investigator
Recruiting
Illinois
Northwestern University, Chicago, Illinois, 60611, United States
Emma Schmidt, Contact, 13125034362, [email protected]
Senda Ajroud-Driss, Principal Investigator
Recruiting
Massachusetts
Lahey Clinic, Burlington, Massachusetts, 01805, United States
Sorieba Fofanah, Contact, 781-744-2958, [email protected]
Melo Catia, Contact, [email protected]
Medhi Ghasemi, MD, Principal Investigator
Recruiting
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
Anne Vallis, Contact, 13139161364, [email protected]
Ximena Arcila Londono, Principal Investigator
Recruiting
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55455, United States
Valerie Ferment, Contact, 16123011535, [email protected]
David Walk, Principal Investigator
Recruiting
Missouri
Saint Louis University, St Louis, Missouri, 63104, United States
Katie Forsman, Contact, [email protected]
Ghazala Hayat, Principal Investigator
Recruiting
Oregon
Providence ALS Clinic, Portland, Oregon, 97213, United States
Tyler Regan, Contact, 15032152333, [email protected]
Nicholas Olney, Principal Investigator
Recruiting
Pennsylvania
Temple University Lewis Katz School of Medicine, Philadelphia, Pennsylvania, 19140, United States
John Furey, Contact, 12676940573, [email protected]
Terry Heiman-Patterson, Principal Investigator
Recruiting
University of Pittsburgh, Pittsburgh, Pennsylvania, 15360, United States
Helen Ismail, Contact, 4128642873, [email protected]
Tawfiq Al-lahham, MD, Principal Investigator
Recruiting
Virginia
Virginia Commonwealth University, Richmond, Virginia, 22908, United States
Demetrius Carter, Contact, [email protected]
Kelly Gwathmey, Principal Investigator
Recruiting
Hadassah Medical Organization, Jerusalem, 9112001, Israel
Michal Zabari, Contact, [email protected]
Marc Gotkine, MD, Principal Investigator
Recruiting
Tel Aviv Medical Center, Tel Aviv, 64239, Israel
Beatrice Abramovich, Contact, [email protected]
Vivian Drori, MD, Principal Investigator
Recruiting
Centro Clinico NEMO Milano, Milan, 20162, Italy
Monica Montuori, Contact, [email protected]
Federica Cerri, Principal Investigator
Recruiting
Istituti Clinici Scientifici Maugeri SpA, Milan, 20138, Italy
Camilla Garrè, Contact, [email protected]
Christian Lunetta, MD, Principal Investigator
Rachele Piras, MD, Sub-Investigator
Recruiting