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NCT00136500 Clinical Trial

Clinical Research in ALS Study

Amyotrophic Lateral Sclerosis Clinical Trial

— CRiALS  

Official title:
Clinical Research in Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00136500
Other study ID # 20101021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 2005
Est. completion date December 2027

Study information
Verified date February 2024
Source University of Miami
Contact Anne-Laure Grignon, MD
Phone 888-413-9315
Email fals@med.miami.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10000
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: 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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (3)
Lead Sponsor Collaborator
University of Miami ALS Association, ALS Recovery Fund

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Annually
See also
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Recruiting NCT02917681 - Study of Two Intrathecal Doses of Autologous Mesenchymal Stem Cells for Amyotrophic Lateral Sclerosis Phase 1/Phase 2
Active, not recruiting NCT03067857 - Autologous Bone Marrow-Derived Stem Cell Therapy for Motor Neuron Disease Phase 1/Phase 2
Recruiting NCT02874209 - Noninvasive Assessment of Neuronal Damage by MRI Sodium ( 23Na ) in Amyotrophic Lateral Sclerosis N/A

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