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PRE-Symptomatic Studies in ALS (PRESS-ALS)

This study is currently recruiting participants.
Verified June 2017 by Michael Benatar, University of Miami
Sponsor:
ClinicalTrials.gov Identifier:
NCT01508962
First Posted: January 12, 2012
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Benatar, University of Miami
  Purpose
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.

Condition
Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PRE-Symptomatic Studies in ALS

Resource links provided by NLM:


Further study details as provided by Michael Benatar, University of Miami:

Primary Outcome Measures:
  • Phenoconversion [ Time Frame: Every three months over the course of one year ]

Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: December 2027
Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy individuals (controls)
Individuals affected with ALS (sporadic or familial)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People affected with ALS (either familial or sporadic) and healthy controls
Criteria

Inclusion Criteria

ALS group:

  • Subject is a male or female, aged at least 18 years.
  • 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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508962


Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Anne Cooley, MPH       ACooley@med.miami.edu   
Contact: Ashley Manso    305-243-4614    a.manso@miami.edu   
Sponsors and Collaborators
University of Miami
  More Information

Additional Information:
Responsible Party: Michael Benatar, Professor of Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT01508962     History of Changes
Other Study ID Numbers: PRESS-ALS
First Submitted: January 9, 2012
First Posted: January 12, 2012
Last Update Posted: June 9, 2017
Last Verified: June 2017

Keywords provided by Michael Benatar, University of Miami:
Disease onset
Disease progression

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