NCT01746381 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Aboussouan LS, Khan SU, Meeker DP, Stelmach K, Mitsumoto H
Effect of noninvasive positive-pressure ventilation on survival in amyotrophic lateral sclerosis. Ann Intern Med. 1997 Sep 15;127(6):450-3.
Atkeson AD, RoyChoudhury A, Harrington-Moroney G, Shah B, Mitsumoto H, Basner RC
Patient-ventilator asynchrony with nocturnal noninvasive ventilation in ALS. Neurology. 2011 Aug 9;77(6):549-55. doi: 10.1212/WNL.0b013e318228c0fb. Epub 2011 Jul 27.
McKim DA, Road J, Avendano M, Abdool S, Cote F, Duguid N, Fraser J, Maltais F, Morrison DL, O'Connell C, Petrof BJ, Rimmer K, Skomro R; Canadian Thoracic Society Home Mechanical Ventilation Committee
Home mechanical ventilation: a Canadian Thoracic Society clinical practice guideline. Can Respir J. 2011 Jul-Aug;18(4):197-215.
Pinto AC, Evangelista T, Carvalho M, Alves MA, Sales Luís ML
Respiratory assistance with a non-invasive ventilator (Bipap) in MND/ALS patients: survival rates in a controlled trial. J Neurol Sci. 1995 May;129 Suppl:19-26.
Piper AJ, Sullivan CE
Effects of long-term nocturnal nasal ventilation on spontaneous breathing during sleep in neuromuscular and chest wall disorders. Eur Respir J. 1996 Jul;9(7):1515-22.
Radunovic A, Mitsumoto H, Leigh PN
Clinical care of patients with amyotrophic lateral sclerosis. Lancet Neurol. 2007 Oct;6(10):913-25. Review.

Initiation of Long-term Home Non-invasive Ventilation in Amyotrophic Lateral Sclerosis (ALS) Using the iVAPS Mode During a Daytime Trial

Clinical trial NCT01746381 - References