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Early Treatment of Amyotrophic Lateral Sclerosis (ALS) With Nutrition and Non-Invasive Positive Pressure Ventilation

NCT00116558 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2019-07-31

Study results available
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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.

Conditions

Interventions

DEVICE

Early NIPPV

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

DEVICE

Standard NIPPV

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Edward Kasaraskis

    lead OTHER

Principal Investigators

  • Edward Kasarskis, MD, PhD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-01
Primary Completion
2012-01-31
Completion
2012-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00116558 on ClinicalTrials.gov