An observational study in ALS, PLS and MND (Motor Neurone DIsease), sponsored by Massachusetts General Hospital. Recruiting at 18 sites in 3 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Massachusetts General Hospital · Observational
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Among 20 studies in Amyotrophic Lateral Sclerosis by Massachusetts General Hospital — 3 open to participants now, 3 under way, none of them phase 3. Amyotrophic Lateral Sclerosis · Massachusetts General Hospital.
Among the 20 studies in Amyotrophic Lateral Sclerosis by Massachusetts General Hospital, this one has the largest planned enrollment of the 10 observational ones that give a count, is one of 4 that started in 2015, is one of 10 observational ones, and was the 17th registered.
980 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 279 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →3 of the 20 studies in Amyotrophic Lateral Sclerosis by Massachusetts General Hospital are open now, in 3 countries. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 18+
Massachusetts General Hospital · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 193 Amyotrophic Lateral Sclerosis studies recruiting now, 118 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 3 2
First in 2006; this study’s year is marked. 4 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 5,000 is above the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.
Median enrollment 37 across the 10 interventional studies, 130 across the 10 observational. Of the 16 that completed or were terminated, 8 (50%) have results posted.
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Massachusetts General Hospital is the lead sponsor of 2,589 studies on the registry; 447 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
1 of the studies in Amyotrophic Lateral Sclerosis by Massachusetts General Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06968468Massachusetts General HospitalResiliency Intervention for Patients With ALS and Their Care-Partners | 2027-02-13 |
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Among the 20 studies in Amyotrophic Lateral Sclerosis by Massachusetts General Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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 Identifier (NeuroGUID) and its study-specific derivative, NeuroSTAmP, which is used to link this Study's information to biological samples, images, and clinical data obtained from those individuals in this Study and other studies/trials, in which these patients participate(d).
The following information is captured in NeuroBANK platform:
Baseline information
Other Key Features
The site should track numbers of patients who declined participation. The site should have a mechanism in place to include an offer of participation to each patient in clinic (consenting does not require immediate data entry) Regular Data Quality checks may be performed at the site. Site personnel who intend to have access to NeuroBANK are trained and certified prior to given access.
Several registries, both cross-sectional and longitudinal, currently exist in ALS. NeuroBANK is distinct from other current registries in that it is a patient-centered platform that is designed to function as a data repository of patient data from clinical visits and multiple clinical research projects as well as linking these data to biorepository for tissue, imaging, and other biological information. This natural history study can act as a clinical research framework that may link clinical and clinical research data from current and past studies with biological specimens and image collections.
With obtained consents, biological specimens may be collected with bar-coded labels containing patient assigned study specific NeuroSTAmPs, printed from within NeuroBANK, and scanned into NeuroBANK's virtual distributed BioRepository module. Imaging studies are de-identified with NeuroSTAmPs and linked to clinical and phenotypical information. Anonymized clinical data obtained through this protocol are available to other researchers.
Study Population
Individuals who are seen during their clinical care visits are asked to allow their data to be uploaded and captured for clinical research. The NeuroBANK platform is located at and managed by the Center for Innovation and Bioinformatics (CIB), Neurological Clinical Research Institute (NCRI) of Massachusetts General Hospital (Boston, MA).
Consent Process
Every participant in the ALS clinic is approached to participate in this study. A signed informed consent form is obtained before any data are recorded for study purposes.
All people living with ALS/MND at participating multidisciplinary ALS/MND clinics
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: Every 3-4 months up to 5 years
Slow Vital Capacity (SVC)
Slow vital capacity test normalized to age, sex, and height
Time frame: 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..
Time frame: Every 3-4 months up to 5 years
Vital Signs
Vital Signs (Weight, BP, HR). Both systolic and diastolic pressure are measured.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Every 3-4 months up to 5 years
Grip Strength Testing
Grip Strength Testing
Time frame: 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
Time frame: Every 3-4 months up to 5 years
5 Times Sit to Stand
5 Times Sit to Stand Test
Time frame: Every 3-4 months up to 5 years
10 Meter Walk Test
10 Meter Walk Test
Time frame: 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
Time frame: Through study completion, annually up to 5 years
Plan to share: Yes — Anonymized IPD are being shared with data requestors upon submission of the research proposal online. Data Access Committee reviews submissions and upon approval and execution of the Data Sharing Agreement, the dataset is provided to the data requestor.
Supporting information: Study protocol
Time frame: 10-30 days from the initial request's online submission
Access criteria: ALS/MND Natural History Consortium's Data Access committee reviews the merits of the requestors' research proposals and approves or denies data access
Started Apr 2015 (actual). Primary completion is estimated for Dec 2030, 188 months after the start.
Of 128 non-industry observational studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 125. This study's planned 188 months is above that.
Counting every sponsor, half of 137 studies reached it within 64 months; a quarter within 29 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Amyotrophic Lateral Sclerosis →
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