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NCT01508962 Clinical Trial

PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

— PRESS-ALS  

Official title:
PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01508962
Other study ID # PRESS-ALS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 2013
Est. completion date December 2027

Study information
Verified date February 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 100
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Phenoconversion Every three months over the course of one year
See also
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