Clinical Research in ALS

Study 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).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Observational Study

Study Category:

Diseases, Study Type, Study Status, Phase, Gender

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Michael Benatar, MD, PhD. University of Miami

Clinicaltrials.gov ID (11 digit #):

NCT00136500

Neals Affiliated?

No

Coordinating Center Contact Information

University of Miami
Eliana Reyes / .(JavaScript must be enabled to view this email address) / 888-413-9315
.(JavaScript must be enabled to view this email address) Miami, Florida 33136 United States

Full Study Summary:

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.

Study Sponsor:

ALS Association; ALS Recovery Fund

Participant Duration:

Estimated Enrollment:

10000

Estimated Study Start Date:

01/31/2005

Estimated Study Completion Date:

11/30/2019

Posting Last Modified Date:

06/30/2016

Date Study Added to alsconsortium.org:

08/19/2015
  • More Information

    https://clinicalt...CT00136500&rank=1

  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    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:
    -Member of at least one of the following categories:
    a. Individuals affected with ALS or a related neurodegenerative disease (sporadic or familial)
    b. Unaffected individuals from fALS pedigrees, including pre-symptomatic individuals at genetic risk for ALS or individuals from pedigrees of ALS related diseases.
    c. 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).

  • Site Contact Information

    University of Miami
    Eliana Reyes / .(JavaScript must be enabled to view this email address) / 888-413-9315
    Miami, Florida 33136
    United States