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

Completed · Phase 1 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT00580593

Run by

University of Michigan

People needed

60

Starts

2007-04-01

Expected to finish

2012-03-01

Last updated by the study team

2013-07-10

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years old
• Probable or possible ALS by El Escorial criteria
• If of child-bearing potential, has a negative urine or serum pregnancy test

You may not qualify if…

• FVC < 50% predicted for age
• Previous pneumothorax
• Bullous emphysema
• Requirement for oxygen
• Previous use of any positive pressure ventilation equipment (continuous positive airway pressure, or bilevel positive airway pressure)
• Current involvement in a clinical treatment trial
• Any unstable medical condition thought likely to interfere with participation

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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