PRE-Symptomatic Studies in ALS (PRESS-ALS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Michael Benatar, University of Miami
ClinicalTrials.gov Identifier:
NCT01508962
First received: January 9, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition
Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Phenoconversion [ Time Frame: Every three months over the course of one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy individuals (controls)
Individuals affected with ALS (sporadic or familial)

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

For individuals with ALS: At least one region (e.g. arm, leg, bulbar) must still be clinically unaffected.

For healthy controls: No family history of ALS or a related disorder

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508962

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Michael Benatar, MD, PhD    305-243-6480    mbenatar@med.miami.edu   
Contact: Sara-Claude Michon, PhD (coordinator)    305-243-6481    scmichon@med.miami.edu   
Sponsors and Collaborators
University of Miami
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Benatar, Professor of Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT01508962     History of Changes
Other Study ID Numbers: PRESS-ALS
Study First Received: January 9, 2012
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Disease onset
Disease progression

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Motor Neuron Disease
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on September 22, 2014