Clinical Research in ALS Study (CRiALS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00136500 |
Recruitment Status :
Recruiting
First Posted : August 29, 2005
Last Update Posted : April 13, 2022
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Condition or disease |
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Amyotrophic Lateral Sclerosis |
Study Type : | Observational |
Estimated Enrollment : | 10000 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Clinical Research in Amyotrophic Lateral Sclerosis |
Study Start Date : | February 2005 |
Estimated Primary Completion Date : | December 2027 |
Estimated Study Completion Date : | December 2027 |

Group/Cohort |
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Individuals affected with ALS
This population be sporadic or familial ALS.
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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).
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Individuals affected with an ALS-related neurodegenerative disease
This would include FTD, MSP, IBMPFD, etc.
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Healthy controls |
- Recruitment [ Time Frame: Annually ]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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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:
- At least 18 years of age.
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Member of at least one of the following categories:
- Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial)
- Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases.
- Healthy controls
- Able and willing to comply with relevant procedures.
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136500
Contact: Anne-Laure Grignon, MD | 888-413-9315 | fals@med.miami.edu |
United States, Florida | |
University of Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Anne-Laure Grignon, MD 888-413-9315 fals@med.miami.edu |
Principal Investigator: | Michael Benatar, MD, PhD. | University of Miami |
Responsible Party: | Michael Benatar, Professor, University of Miami |
ClinicalTrials.gov Identifier: | NCT00136500 |
Other Study ID Numbers: |
20101021 |
First Posted: | August 29, 2005 Key Record Dates |
Last Update Posted: | April 13, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
genetics biomarkers pre-symptomatic natural history |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |