Status:
ACTIVE_NOT_RECRUITING
PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis
Lead Sponsor:
University of Miami
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
November 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2037
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01508962
Start Date
November 1 2013
End Date
December 1 2037
Last Update
February 26 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136