RECRUITING

Adenosine 2A Receptor Antagonism and AIH in ALS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Acute Adenosine Receptor Antagonism to Promote Breathing Plasticity in ALS

Quick Facts

Study Start:2022-06-21

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05377424

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Non-smoking adults aged 21-80 years will be eligible to participate. 2. ALS diagnosis (El Escorial diagnostic classifications of probable/definite ALS), 3. vital capacity (VC) \> 60% of predicted value, and 4. ALS Functional Rating Scale (ALSFRS-R) scores of 2 or greater for bulbar and respiratory items: swallowing, speech, salivation, dyspnea, orthopnea, and respiratory insufficiency. 5. Additionally, patients taking riluzole and/or edaravone must be on a stable dose for \>30 days. 6. Unaffected control subjects will be eligible if they have a vital capacity (VC) \> 60% of predicted value.	1. are pregnant 2. have an active respiratory infection, 3. took antibiotics within 4 weeks, 4. are diagnosed with another neurodegenerative disease, 5. have symptomatic cardiovascular disease or dysrhythmias (resting tachycardia and hypertension), 6. exhibit history or presence of hypoxemia or hypercapnia, 7. presence of rest tachypnea (RR ˃30), 8. have a BMI \>35 kg/m2, 9. have a seizure disorder, 10. take respiratory inhalers daily for airway disease, or 11. require external respiratory support while awake and upright, or 12. supplemental oxygen at rest or at night. 13. In addition, the following conditions are exclusionary for the use of istradefylline: routine use of CYP3A4 inducers (i.e. carbamazepine, phenobarbitol, rifampin, phenytoin, St. John's Wort, glucocorticoids) or 14. medications that may suppress ventilation, history of moderate renal impairment or severe hepatic impairment, and history of hallucinations or psychosis. 15. Patients who cannot safety swallow thin liquids (required for administration of istradefylline and placebo) will also be ineligible.

Inclusion Criteria

Exclusion Criteria

1. Non-smoking adults aged 21-80 years will be eligible to participate.
2. ALS diagnosis (El Escorial diagnostic classifications of probable/definite ALS),
3. vital capacity (VC) \> 60% of predicted value, and
4. ALS Functional Rating Scale (ALSFRS-R) scores of 2 or greater for bulbar and respiratory items: swallowing, speech, salivation, dyspnea, orthopnea, and respiratory insufficiency.
5. Additionally, patients taking riluzole and/or edaravone must be on a stable dose for \>30 days.
6. Unaffected control subjects will be eligible if they have a vital capacity (VC) \> 60% of predicted value.

1. are pregnant
2. have an active respiratory infection,
3. took antibiotics within 4 weeks,
4. are diagnosed with another neurodegenerative disease,
5. have symptomatic cardiovascular disease or dysrhythmias (resting tachycardia and hypertension),
6. exhibit history or presence of hypoxemia or hypercapnia,
7. presence of rest tachypnea (RR ˃30),
8. have a BMI \>35 kg/m2,
9. have a seizure disorder,
10. take respiratory inhalers daily for airway disease, or
11. require external respiratory support while awake and upright, or
12. supplemental oxygen at rest or at night.
13. In addition, the following conditions are exclusionary for the use of istradefylline: routine use of CYP3A4 inducers (i.e. carbamazepine, phenobarbitol, rifampin, phenytoin, St. John's Wort, glucocorticoids) or
14. medications that may suppress ventilation, history of moderate renal impairment or severe hepatic impairment, and history of hallucinations or psychosis.
15. Patients who cannot safety swallow thin liquids (required for administration of istradefylline and placebo) will also be ineligible.

Contacts and Locations

Study Contact

Julia Prascak, BS

CONTACT

3522736855

juliaprascak@ufl.edu

Principal Investigator

Barbara Smith

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

Clinical and Translational Research Building

Gainesville, Florida, 32610

United States

UF Health Jacksonville

Jacksonville, Florida, 32209

United States

Collaborators and Investigators

Sponsor: University of Florida

Barbara Smith, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-21

Study Completion Date2025-12-31

Study Record Updates