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NCT05377424 · ClinicalTrials.gov registry record · Phase 1
Adenosine 2A Receptor Antagonism and AIH in ALS
A Phase 1 study of ALS, sponsored by University of Florida.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT05377424 is a Phase 1 study of ALS that is active but no longer recruiting, run by University of Florida. The registered enrollment target is 40 participants, below the 1,035-participant average among 19 other ALS trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05377424, a Phase 1 study of ALS, is active but no longer recruiting, sponsored by University of Florida.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
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.
Conditions Studied
Interventions
- DRUG Consume 20mg of istradefylline
- OTHER Low Oxygen therapy
- DRUG Placebo counterpart to the istradefylline drug
- OTHER SHAM counterpart to low oxygen therapy.
Study Locations (2)
Florida
- Clinical and Translational Research Building - Gainesville
- UF Health Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-06-21 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05377424
The ClinicalTrials.gov registry entry for NCT05377424 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,035-participant average among 19 other ALS trials with a reported enrollment target (96% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with ALS appearing as the primary indexed condition, and to 4 interventions - of which Consume 20mg of istradefylline is the first listed.
NCT05377424 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT05377424 about?
NCT05377424 is a clinical study titled "Adenosine 2A Receptor Antagonism and AIH in ALS". 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 late...
What is the current status of trial NCT05377424?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-06-21. Estimated completion is 2026-08-31.
What conditions does trial NCT05377424 study?
This clinical trial studies the following conditions: ALS.
What interventions are being tested in trial NCT05377424?
The interventions under investigation include: Consume 20mg of istradefylline (DRUG), Low Oxygen therapy (OTHER), Placebo counterpart to the istradefylline drug (DRUG), SHAM counterpart to low oxygen therapy. (OTHER).
Who is sponsoring clinical trial NCT05377424?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05377424 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.