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Adenosine 2A Receptor Antagonist

Istradefylline and AIH for ALS

Phase 1 & 2

Recruiting

Led By Barbara Smith

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unaffected control subjects with vital capacity (VC) > 60% of predicted value

Non-smoking adults aged 21-80 years

Must not have

Individuals with active respiratory infection

Individuals with routine use of CYP3A4 inducers or medications that may suppress ventilation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes after aih

Summary

This trial will study whether istradefylline can improve or maintain breathing in people with ALS when used before AIH.

Who is the study for?

Adults aged 21-75 with ALS, non-smokers, having a vital capacity over 60% of predicted value and an ALSFRS-R score above 30. They must not have used antibiotics recently or have certain respiratory or cardiovascular issues. Stable doses of riluzole/edaravone for over 30 days are required if in use.

What is being tested?

The trial tests the effects of a drug called istradefylline and low oxygen therapy on breathing in ALS patients compared to placebos. It aims to see if these treatments help patients take deeper breaths without causing discomfort.

What are the potential side effects?

Potential side effects may include difficulty swallowing (due to the pill form), risk of hallucinations or psychosis from the drug, and possible suppression of ventilation due to medication interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung function is more than 60% of what is expected for someone my age and size.

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I am between 21 and 80 years old and do not smoke.

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My lung function is more than 60% of what is expected.

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I have been diagnosed with ALS.

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I can swallow, speak, and breathe with minimal difficulty.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have an active respiratory infection.

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I regularly take medications that affect liver enzymes or breathing.

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I have heart problems like irregular heartbeat or high blood pressure.

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I have had moderate kidney problems or severe liver issues.

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My BMI is over 35.

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I have had hallucinations or psychosis in the past.

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I cannot safely swallow thin liquids.

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I have a condition that causes seizures.

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I need help breathing when awake or need extra oxygen.

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I have a history of low oxygen or high carbon dioxide levels in my blood.

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I have been diagnosed with a neurodegenerative disease.

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I breathe very fast when resting.

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I use a daily inhaler for my lung condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes after aih

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 minutes after aih

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes after aih for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in resting tidal volume

Treatment differences in the rate of adverse events.

Secondary study objectives

Change in minute ventilation

Serum Istradefylline

Subject-reported involuntary movements

Other study objectives

Change in maximal voluntary pinch force

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: AIH + istradefylline (AIH+IST)Experimental Treatment2 Interventions

Participants enrolled in this study arm will ingest a 20mg tablet containing istradefylline. Four hours later, participants will receive acute intermittent hypoxia (AIH). Breathing and pinch strength will be tested prior to taking the medication, and then immediately before, 60 minutes and 120 minutes after AIH. Participants will breathe 15 episodes/session of acute low oxygen. Air concentrations will be monitored to ensure delivery of 1-minute episodes of low oxygen, with 2 minutes room-air intervals. Respiratory rate, oxygen saturation, heart rate/rhythm, and blood pressure will be monitored throughout the session.

Group II: Sham-AIH + placebo (sham+CON)Active Control2 Interventions

This is a sham counterpart to low oxygen, and a placebo counterpart to the istradefylline drug. Participants enrolled in this study arm will ingest a 20mg tablet containing microcrystalline cellulose. Four hours later, participants will receive SHAM acute intermittent hypoxia (SHAM). Breathing and pinch strength will be tested prior to taking the medication, and then immediately before, 60 minutes and 120 minutes after SHAM. Participants will breathe 15 episodes/session of sham low oxygen, in which normal air is used. One-minute episodes of sham low oxygen are separated by 2 minutes room-air intervals. Respiratory rate, oxygen saturation, heart rate/rhythm, and blood pressure will be monitored throughout the session.

Group III: AIH + placebo (AIH+CON)Active Control2 Interventions

This is a placebo counterpart to the istradefylline drug. Participants enrolled in this study arm will ingest a 20mg tablet containing microcrystalline cellulose. Four hours later, participants will receive acute intermittent hypoxia (AIH). Breathing and pinch strength will be tested prior to taking the medication, and then immediately before, 60 minutes and 120 minutes after AIH. Participants will breathe 15 episodes/session of acute low oxygen. Air concentrations will be monitored to ensure delivery of 1-minute episodes of low oxygen, with 2 minutes room-air intervals. Respiratory rate, oxygen saturation, heart rate/rhythm, and blood pressure will be monitored throughout the session.

Group IV: Sham-AIH + istradefylline (sham+IST)Active Control2 Interventions

This is a sham counterpart to the low oxygen. Participants enrolled in this study arm will ingest a 20mg tablet containing istradefylline. Four hours later, participants will receive SHAM acute intermittent hypoxia (SHAM). Breathing and pinch strength will be tested prior to taking the medication, and then immediately before, 60 minutes and 120 minutes after SHAM. Participants will breathe 15 episodes/session of sham low oxygen, in which normal air is used. One-minute episodes of sham low oxygen are separated by 2 minutes room-air intervals. Respiratory rate, oxygen saturation, heart rate/rhythm, and blood pressure will be monitored throughout the session.

0 / 18Eligibility criteria met