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NCT00386464 · ClinicalTrials.gov registry record · Phase 2
Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00386464: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT00386464 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00386464, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Non-invasive ventilation or BiPAP®, which is a form of breathing support delivered through a facemask, is a successful treatment for the respiratory complications of amyotrophic lateral sclerosis (ALS). It has been shown to prolong survival, improve quality of life, and improve cognitive function. It is widely used among patients with ALS who have advanced breathing difficulties. It is not known whether there is benefit to using non-invasive ventilation earlier in the disease course. There is evidence that non-invasive ventilation may slow down the decline in breathing function. If this were true then it would make sense to start non-invasive ventilation use earlier than the current clinically accepted practices. The purpose of this study is to determine whether using non-invasive ventilation early in the course of disease can slow the decline in breathing function. Patients remain in the study for 6 months and are asked to make 7 clinic visits during which time they will undergo pulmonary function tests and complete questionnaires.
Interventions
- DEVICE noninvasive positive pressure ventilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-04 |
| Est. Completion | 2007-09 |
| Phase | Phase 2 |
What the finished NCT00386464 record still lists
NCT00386464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which noninvasive positive pressure ventilation is the first listed.
NCT00386464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00386464 about?
NCT00386464 is a clinical study titled "Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement". Non-invasive ventilation or BiPAP®, which is a form of breathing support delivered through a facemask, is a successful treatment for the respiratory complications of amyotrophic lateral sclerosis (ALS). It has been shown to prolong survival, improve quality of life, and improve cognitive function. I...
What is the current status of trial NCT00386464?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2002-04. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00386464?
The interventions under investigation include: noninvasive positive pressure ventilation (DEVICE).
Who is sponsoring clinical trial NCT00386464?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00386464's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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