Amyotrophic Lateral SclerosisPRESS-ALSNCT01508962
PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People affected with ALS (either familial or sporadic) and healthy controls
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Disease onset, Disease progression
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals (controls) | Not described | |
| Individuals affected with ALS (sporadic or familial) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phenoconversion
Measured: Every three months over the course of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startNov 2013
- Primary completionDec 2037 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Benatar, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508962
- Sponsor's protocol ID
- PRESS-ALS
- Acronym
- PRESS-ALS
- Status last verified
- Mar 2026
- First submitted
- 9 Jan 2012
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRE-Symptomatic Studies in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT01508962
- Acronym / sponsor ID
- PRESS-ALS / PRESS-ALS
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Disease onset, Disease progression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2037 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals (controls) | – | – |
| Individuals affected with ALS (sporadic or familial) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People affected with ALS (either familial or sporadic) and healthy controls
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phenoconversion
Time frame: Every three months over the course of one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenoconversion (time frame: Every three months over the course of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.