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

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

Tracking Information

• First Submitted Date: January 9, 2012
• First Posted Date: January 12, 2012
• Last Update Posted Date: March 10, 2023
• Study Start Date: November 2013
• Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 2, 2013): Phenoconversion [ Time Frame: Every three months over the course of one year ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis
• Official Title: PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: People affected with ALS (either familial or sporadic) and healthy controls
• Condition: Amyotrophic Lateral Sclerosis
• Intervention: Not Provided

Study Groups/Cohorts

• Healthy individuals (controls)
• Individuals affected with ALS (sporadic or familial)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 2, 2013): 100
• Original Enrollment: Not Provided
• Estimated Study Completion Date: December 2027
• Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01508962
• Other Study ID Numbers: PRESS-ALS
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Michael Benatar, University of Miami
• Original Responsible Party: Michael Benatar, University of Miami, Associate Professor of Neurology
• Current Study Sponsor: University of Miami
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Miami
• Verification Date: March 2023