Status:
RECRUITING
Adenosine 2A Receptor Antagonism and AIH in ALS
Lead Sponsor:
University of Florida
Collaborating Sponsors:
ALS Association
Conditions:
ALS
Eligibility:
All Genders
21-80 years
Phase:
PHASE1
PHASE2
Brief 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 intermitte...
Detailed Description
This repeated measures, placebo-controlled, randomized study will study feasibility and efficacy of istradefylline, an adenosine 2A receptor antagonist in conjunction with acute intermittent hypoxia (...
Eligibility Criteria
Inclusion
- Non-smoking adults aged 21-80 years will be eligible to participate.
- \- Upon screening, eligible patients will have an
- ALS diagnosis (El Escorial diagnostic classifications of probable/definite ALS),
- vital capacity (VC) \> 60% of predicted value, and
- ALS Functional Rating Scale (ALSFRS-R) scores of 2 or greater for bulbar and respiratory items: swallowing, speech, salivation, dyspnea, orthopnea, and respiratory insufficiency.
- Additionally, patients taking riluzole and/or edaravone must be on a stable dose for \>30 days.
- Unaffected control subjects will be eligible if they have a vital capacity (VC) \> 60% of predicted value.
Exclusion
- Patient and control are ineligible if they
- are pregnant
- have an active respiratory infection,
- took antibiotics within 4 weeks,
- are diagnosed with another neurodegenerative disease,
- have symptomatic cardiovascular disease or dysrhythmias (resting tachycardia and hypertension),
- exhibit history or presence of hypoxemia or hypercapnia,
- presence of rest tachypnea (RR ˃30),
- have a BMI \>35 kg/m2,
- have a seizure disorder,
- take respiratory inhalers daily for airway disease, or
- require external respiratory support while awake and upright, or
- supplemental oxygen at rest or at night.
- 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
- medications that may suppress ventilation, history of moderate renal impairment or severe hepatic impairment, and history of hallucinations or psychosis.
- Patients who cannot safety swallow thin liquids (required for administration of istradefylline and placebo) will also be ineligible.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05377424
Start Date
June 21 2022
End Date
May 31 2026
Last Update
July 15 2025
Active Locations (2)
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1
Clinical and Translational Research Building
Gainesville, Florida, United States, 32610
2
UF Health Jacksonville
Jacksonville, Florida, United States, 32209