CClinicalTrials.gg
RecruitingNCT00136500CRiALSUpdated Mar 20, 2026

Clinical Research in ALS Study

An observational study in Amyotrophic Lateral Sclerosis, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by University of Miami · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
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Study summary

CRiALS is an umbrella protocol through which people are recruited to participate in a range of research studies being conducted by the ALS Research Collaboration (ARC).

Read the detailed description

Research goals include elucidation of the complex relationship between ALS and related neurodegenerative disorders, development of both wet and dry biomarkers of disease, and delineation of the full course of the natural history of disease from the early pre-symptomatic stages through established and even late-stage disease. These goals are accomplished through the recruitment and evaluation of patients with ALS and related diseases, family members (including people at genetic risk for ALS, but who are not yet affected), and healthy controls.

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Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • genetics
  • biomarkers
  • pre-symptomatic
  • natural history
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In context

Amyotrophic Lateral Sclerosis

981 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 283 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 106 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The CRiALS research program aims to recruit three types of participants:

  • Individuals affected with ALS or a related neurodegenerative disease
  • Unaffected individuals from pedigrees in which the genetic cause of ALS is known
  • Healthy controls

Inclusion criteria

  1. At least 18 years of age.
  2. Member of at least one of the following categories:

    1. Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial)
    2. Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases.
    3. Healthy controls
  3. Able and willing to comply with relevant procedures.

Exclusion criteria

Exclusion Criteria:

1. Subject has a condition or is in a situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol -- including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Individuals affected with ALS

    This population be sporadic or familial ALS.

  • Unaffected individuals from families in which the genetic cause of ALS is known

    This population includes pre-symptomatic individuals at genetic risk for ALS or a related neurodegenerative disorder (i.e., FTD).

  • Individuals affected with an ALS-related neurodegenerative disease

    This would include FTD, MSP, IBMPFD, etc.

  • Healthy controls
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What researchers measure

Primary outcomes

  1. Recruitment

    Since this is an umbrella/gateway protocol through which individuals are recruited to participate in a range of studies, outcome is assessed in terms of recruitment.

    Time frame: Annually

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Study locations

1 of 1 sites recruiting
  • University of Miami
    Miami, Florida 33136, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00136500
Lead sponsor
University of Miami
Collaborators
ALS Association, ALS Recovery Fund
Responsible party
Michael Benatar (Professor, University of Miami) — Principal investigator
First posted
Aug 29, 2005
Start date
Feb 2005
Primary completion
Dec 2037 (estimated)
Completion
Dec 2037 (estimated)
Last update
Mar 20, 2026

Study contacts

Anne-Laure Grignon, MD
Contact
fals@med.miami.edu
888-413-9315
Michael Benatar, MD, PhD.
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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