Low Oxygen therapy for Amyotrophic Lateral Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Clinical and Translational Research Building, Gainesville, FL
Amyotrophic Lateral Sclerosis
Low Oxygen therapy - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this research study is to determine the effects of a medication, istradefylline, in conjunction with breathing air with reduced oxygen for short periods of time (called acute intermittent hypoxia, or AIH), on breathing. This project will study breathing in people with amyotrophic lateral sclerosis (ALS) and unaffected, age-matched adults. Istradefylline is prescribed to increase movement in people with other neuromuscular conditions. A recently completed study found that people with ALS took deeper breaths, 60 minutes after using AIH.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Amyotrophic Lateral Sclerosis

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 120 minutes after AIH

120 minutes after AIH
Change in resting tidal volume
120 minutes post-intervention.
Change in maximal voluntary pinch force
Change in minute ventilation
Hour 4
Subject-reported involuntary movements
Hour 6
Serum Istradefylline
Week 6
Treatment differences in the rate of adverse events.

Trial Safety

Safety Progress

1 of 3

Other trials for Amyotrophic Lateral Sclerosis

Trial Design

4 Treatment Groups

AIH + placebo (AIH+CON)
1 of 4
Sham-AIH + istradefylline (sham+IST)
1 of 4
Sham-AIH + placebo (sham+CON)
1 of 4
AIH + istradefylline (AIH+IST)
1 of 4
Active Control
Experimental Treatment

40 Total Participants · 4 Treatment Groups

Primary Treatment: Low Oxygen therapy · Has Placebo Group · Phase 1 & 2

AIH + istradefylline (AIH+IST)Experimental Group · 2 Interventions: Low Oxygen therapy, Consume 20mg of istradefylline · Intervention Types: Other, Drug
AIH + placebo (AIH+CON)ActiveComparator Group · 2 Interventions: Low Oxygen therapy, Placebo counterpart to the istradefylline drug · Intervention Types: Other, Drug
Sham-AIH + istradefylline (sham+IST)ActiveComparator Group · 2 Interventions: Consume 20mg of istradefylline, SHAM counterpart to low oxygen therapy. · Intervention Types: Drug, Other
Sham-AIH + placebo (sham+CON)ActiveComparator Group · 2 Interventions: Placebo counterpart to the istradefylline drug, SHAM counterpart to low oxygen therapy. · Intervention Types: Drug, Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 120 minutes after aih
Closest Location: Clinical and Translational Research Building · Gainesville, FL
Photo of Gainesville 1Photo of Gainesville 2Photo of florida 3
2019First Recorded Clinical Trial
0 TrialsResearching Amyotrophic Lateral Sclerosis
1 CompletedClinical Trials

Who is running the clinical trial?

ALS AssociationOTHER
41 Previous Clinical Trials
16,536 Total Patients Enrolled
39 Trials studying Amyotrophic Lateral Sclerosis
16,465 Patients Enrolled for Amyotrophic Lateral Sclerosis
University of FloridaLead Sponsor
1,228 Previous Clinical Trials
696,403 Total Patients Enrolled
7 Trials studying Amyotrophic Lateral Sclerosis
493 Patients Enrolled for Amyotrophic Lateral Sclerosis
Barbara SmithPrincipal InvestigatorUniversity of Florida

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are taking riluzole and/or edaravone.
You have a vital capacity (VC) > 60% of predicted value.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.