Clinical Research in ALS (CRiALS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Miami
Sponsor:
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: September 8, 2014
Last verified: September 2014

August 25, 2005
September 8, 2014
February 2005
September 2019   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00136500 on ClinicalTrials.gov Archive Site
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Clinical Research in ALS
Clinical Research in ALS

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).

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.

Observational
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

DNA, blood, urine, CSF, skin biopsies

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
Amyotrophic Lateral Sclerosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
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September 2019   (final data collection date for primary outcome measure)

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:

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).

Both
18 Years and older
Yes
Contact: Eliana Reyes 888-413-9315 fals@med.miami.edu
United States
 
NCT00136500
FALS feasibility
No
Michael Benatar, University of Miami
Michael Benatar
  • ALS Association
  • ALS Recovery Fund
Principal Investigator: Michael Benatar, MD, PhD. University of Miami
University of Miami
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP