PRE-Symptomatic Studies in ALS

Study Purpose:

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, University of Miami

Clinicaltrials.gov ID (11 digit #):

NCT01508962

Neals Affiliated?

No

Coordinating Center Contact Information

University of Miami
Anne Cooley, MPH Study Coordinator / .(JavaScript must be enabled to view this email address) / 305-243-0108
.(JavaScript must be enabled to view this email address) Miami, Florida 33136 United States

Full Study Summary:

The goal of PRESS-ALS is to study the earliest manifestations of disease in people with early ALS in whom some areas of the body are not yet affected.

Study Sponsor:

University of Miami

Participant Duration:

Estimated Enrollment:

100

Estimated Study Start Date:

10/31/2013

Estimated Study Completion Date:

11/30/2018

Posting Last Modified Date:

06/30/2016

Date Study Added to alsconsortium.org:

08/19/2015
  • More Information
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Inclusion Criteria

    ALS group:
    -Subject is affected with ALS (familial or sporadic).
    -Subject has at least one limb in which there is no symptomatic upper and lower motor neuron dysfunction.
    -Subject is willing and able to comply with all study procedures.
    -Subject agrees to provide signed and dated informed consent form.

    Control group:
    -Subject is a male or female, aged at least 18 years.
    -Subject is not affected with ALS or an ALS-related disorder.
    -Subject does not have a family history (i.e., at least 2 biological relatives) of ALS or an ALS-related disorder.
    -Subject is willing and able to comply with all study procedures.
    -Subject agrees to provide signed and dated informed consent form.

    Exclusion Criterion
    • Any condition or situation which, in the PI's opinion, could confound the biomarker data 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
    Sara-Claude Michon, PhD (coordinator) / .(JavaScript must be enabled to view this email address) / 305-243-6481
    Miami, Florida 33136
    United States