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OpenTrials
Active, Not Recruiting

NCT Number: NCT01508962

PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Disease Attributes Disease Progression Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Phenoconversion

    Time frame: Every three months over the course of one year

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Acronym: PRESS-ALS

Important dates

Study start
2013
Primary completion
2037
Study completion
2037
First posted
Jan 12, 2012
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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