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PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis (PRESS-ALS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01508962
Recruitment Status : Active, not recruiting
First Posted : January 12, 2012
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
Michael Benatar, University of Miami

Study Description
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Brief 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.

Condition or disease
Amyotrophic Lateral Sclerosis

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis
Study Start Date : November 2013
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Healthy individuals (controls)
Individuals affected with ALS (sporadic or familial)


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
More Information
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Additional Information:

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Responsible Party: Michael Benatar, Professor of Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT01508962    
Other Study ID Numbers: PRESS-ALS
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Benatar, University of Miami:
Disease onset
Disease progression
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases