CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 153 enrolled
Drug / intervention
Early NIPPV +1 moredevice
Likely dose
Early NIPPV at 80% FVC; Standard NIPPV at 50% FVCAI-extracted
Key inclusion· 4
  • ✓Diagnosis of clinically possible, definite, probable, or laboratory-supported probable ALS (sporadic or familial) per revised Escorial criteria
  • ✓Onset of progressive weakness within 60 months prior to study enrollment
  • ✓FVC 50-95% of predicted normal (NIPPV arm) or >50% of predicted normal (Nutrition arm)
  • ✓Willing to return for scheduled visits and adhere to protocol requirements
Key exclusion· 6
  • ✕Current use of NIPPV, mechanical ventilation, or tracheostomy at time of consent
  • ✕Other motor neuron disorder or neurological disorder mimicking ALS
  • ✕Other neurodegenerative disease (Parkinson's disease, Alzheimer's disease, etc.)
  • ✕Inflammatory bowel disease or malabsorption syndrome

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00116558
NCT00116558N/ACompleted
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Early Treatment of Amyotrophic Lateral Sclerosis With Nutrition and Non-Invasive Positive Pressure Ventilation

Edward Kasaraskis·interventional·Posted Jun 30, 2005·Updated Jul 31, 2019

In Brief

A clinical study evaluating Early NIPPV and Standard NIPPV for Amyotrophic Lateral Sclerosis. Completed, enrolled 153 participants across 12 sites.

Detailed Summary

The purposes of the study are to determine the energy balance and evaluate the nutritional status of patients with ALS, and to investigate the use of NIPPV as respiratory support to treat patients with ALS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 30, 2005
Enrollment StartAug 1, 2004
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 21.0 years ago

Interventions

Early NIPPVdevice

Early intervention with non-invasive positive pressure ventilation (NIPPV) at 80% forced vital capacity (FVC).

Standard NIPPVdevice

Standard of care non-invasive positive pressure ventilation (NIPPV) at 50% forced vital capacity (FVC).