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NCT07071935 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)
A Phase 2 study, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT07071935: Recruiting Phase 2 study, sponsored by University of Pennsylvania.
NCT07071935 is a Phase 2 study that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07071935, a Phase 2 study, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face. Research has shown that NIV can improve the quality of life and survival of someone with ALS. Unfortunately, NIV is not equally beneficial for everyone. The investigators do not yet know the best time or method for starting NIV in ALS. Europe and Canada allow starting NIV much earlier in ALS than the United States. Current recommendations for starting NIV are based on the opinion of experts rather than large research studies. Medical insurance companies will not cover NIV until significant breathing weakness occurs. After NIV is started, there is no evidence-based guidance on the best way to adjust NIV to benefit patients as much as possible. Some patients have difficulty tolerating NIV, but it is not clear how to identify these individuals ahead of time. The investigators have created a new prediction tool that can identify patients at high risk of breathing problems within the next 6 months. This may help the study team identify who is more likely to benefit from starting NIV early. The investigators have published a paper that shows that NIV helps people with ALS live longer. This paper also showed that patients get more benefit with use NIV for at least 4 hours per day. The investigators published another paper that measured a gas called carbon dioxide (CO2), which goes high if someone's breathing is weakened. This paper showed that patients with ALS may live longer when CO2 levels are lowered using NIV. The investigators also have data suggesting that certain characteristics may predict who is less likely to use NIV at least 4 hours per day. In this study, the investigators
Primary Outcome
Number of days between randomization to first recorded overnight usage of non-invasive ventilation according to ventilation device data download.
Interventions
- DEVICE Non-invasive ventilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-06-11 |
| Est. Completion | 2029-05 |
| Phase | Phase 2 |
What NCT07071935 shows while recruiting
NCT07071935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which Non-invasive ventilation is the first listed.
NCT07071935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07071935 about?
NCT07071935 is a clinical study titled "A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)". Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps ...
What is the current status of trial NCT07071935?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2026-06-11. Estimated completion is 2029-05.
What interventions are being tested in trial NCT07071935?
The interventions under investigation include: Non-invasive ventilation (DEVICE).
Who is sponsoring clinical trial NCT07071935?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07071935's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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