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

March 19, 2026 updated by: Michael Benatar, University of Miami
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 Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

People affected with ALS (either familial or sporadic) and healthy controls

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phenoconversion
Time Frame: Every three months over the course of one year
Every three months over the course of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Estimated)

December 1, 2037

Study Completion (Estimated)

December 1, 2037

Study Registration Dates

First Submitted

January 9, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimated)

January 12, 2012

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRESS-ALS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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