NCT05966038 ALS/MND Natural History Study Data Repository
| NCT ID | NCT05966038 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | ALS |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2015-04-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2015-04-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Alexander Sherman
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05966038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying ALS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05966038 currently recruiting?
Yes, NCT05966038 is actively recruiting participants. Contact the research team at ntarasenko@mgh.harvard.edu for enrollment information.
Where is the NCT05966038 trial being conducted?
This trial is being conducted at Loma Linda, United States, Los Angeles, United States, Gainesville, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT05966038 clinical trial?
NCT05966038 is sponsored by Massachusetts General Hospital. The principal investigator is Alexander Sherman at Massachusetts General Hospital. The trial plans to enroll 5,000 participants.
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