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
  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 ]
    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: September 2019 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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:

  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).

  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

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:
No publications provided

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: September 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
genetics
biomarkers
pre-symptomatic
natural history

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Motor Neuron Disease
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on October 21, 2014