Clinical Research in ALS Study (CRiALS)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified July 2016 by University of Miami
Sponsor:
Michael Benatar
Collaborators:
ALS Association
ALS Recovery Fund
Information provided by (Responsible Party):
Michael Benatar, University of Miami
ClinicalTrials.gov Identifier:
NCT00136500
First received: August 25, 2005
Last updated: July 18, 2016
Last verified: July 2016
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Purpose
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).
| Condition |
|---|
|
Amyotrophic Lateral Sclerosis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Clinical Research in ALS |
Resource links provided by NLM:
Further study details as provided by University of Miami:
Primary Outcome Measures:
- Recruitment [ Time Frame: Annually ] [ Designated as safety issue: No ]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
DNA, blood, urine, CSF, skin biopsies
| Estimated Enrollment: | 10000 |
| Study Start Date: | February 2005 |
| Estimated Primary Completion Date: | December 2019 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Criteria
Inclusion Criteria:
- At least 18 years of age.
-
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:
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).
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136500
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136500
Contacts
| Contact: Eliana Reyes | 888-413-9315 | fals@med.miami.edu |
Locations
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Eliana Reyes 888-413-9315 fals@med.miami.edu | |
Sponsors and Collaborators
Michael Benatar
ALS Association
ALS Recovery Fund
Investigators
| Principal Investigator: | Michael Benatar, MD, PhD. | University of Miami |
More Information
Additional Information:
| Responsible Party: | Michael Benatar, MBChB, MS, DPhil, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00136500 History of Changes |
| Other Study ID Numbers: | FALS feasibility |
| Study First Received: | August 25, 2005 |
| Last Updated: | July 18, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Miami:
|
genetics biomarkers pre-symptomatic natural history |
Additional relevant MeSH terms:
|
Motor Neuron Disease Amyotrophic Lateral Sclerosis Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases |
Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |
ClinicalTrials.gov processed this record on September 30, 2016