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NCT00580593 · ClinicalTrials.gov registry record · Phase 1

Trial of Early Noninvasive Ventilation for Amyotrophic Lateral Sclerosis (ALS)

A Phase 1 study, sponsored by University of Michigan.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT00580593: Completed Phase 1 study, sponsored by University of Michigan.

NCT00580593 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00580593, a Phase 1 study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

The goal of this trial is to determine the feasibility of conducting a randomized, double-blind, placebo-controlled trial of nocturnal noninvasive positive pressure ventilation in persons with amyotrophic lateral sclerosis with an forced vital capacity greater than or equal to 50 percent.

Interventions

  • DEVICE BiPAP® S/T System
  • OTHER sham-NIPPV

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2007-04
Est. Completion 2012-03
Phase Phase 1
University of Michigan

1,327 total trials

What the finished NCT00580593 record still lists

NCT00580593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which BiPAP® S/T System is the first listed.

NCT00580593 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00580593 about?

NCT00580593 is a clinical study titled "Trial of Early Noninvasive Ventilation for Amyotrophic Lateral Sclerosis (ALS)". The goal of this trial is to determine the feasibility of conducting a randomized, double-blind, placebo-controlled trial of nocturnal noninvasive positive pressure ventilation in persons with amyotrophic lateral sclerosis with an forced vital capacity greater than or equal to 50 percent.

What is the current status of trial NCT00580593?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2007-04. Estimated completion is 2012-03.

What interventions are being tested in trial NCT00580593?

The interventions under investigation include: BiPAP® S/T System (DEVICE), sham-NIPPV (OTHER).

Who is sponsoring clinical trial NCT00580593?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00580593's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00580593, the US trial registry maintained by the National Library of Medicine. NCT00580593 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.