What side effects are associated with this type of intervention?

Common treatments for spinal cord injury, particularly those involving adenosine receptor antagonists like Istradefylline, often have side effects such as gastrointestinal issues (nausea and vomiting), dizziness, and anxiety. These side effects can impact patient compliance and overall treatment efficacy. For example, pentoxifylline, another methylxanthine derivative, has been associated with increased nausea and vomiting when used in combination therapies. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting Adenosine 2a Receptor Antagonists for Spinal Cord Injury (SCI). The research on Istradefylline, which is being studied for its potential to improve walking recovery following SCI by limiting the accumulation of extracellular adenosine, is still in the trial phase. Broadly, treatments for SCI focus on managing symptoms and improving functional mobility through various therapeutic approaches, but specific FDA-approved pharmacological treatments targeting adenosine pathways are not yet established.

What other types of research exist?

Promising alternatives to Istradefylline for spinal cord injury patients include ATL-146e, an adenosine A2A agonist, which has demonstrated significant improvements in spinal cord reperfusion outcomes, and low oxygen therapy (LOT) combined with skill-based walking practice, which has shown to enhance walking recovery.

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Adenosine A2a Receptor Antagonist

Istradefylline + Low Oxygen Therapy for Spinal Cord Injury

Phase 1 & 2

Waitlist Available

Led By Randy D Trumbower, PT, PhD

Research Sponsored by Randy Trumbower, PT, PhD

Eligibility Criteria Checklist

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

Must have

Lesion at or below C2 and above T12 with non-progressive etiology

ability to advance one step overground without human assistance

Must not have

Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)

Diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 day after last treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment for spinal cord injury patients that combines breathing low oxygen air with a medication. The goal is to improve walking by strengthening nerve pathways and blocking certain brain effects that could reduce this benefit. Breathing low-oxygen air has shown potential in enhancing walking recovery in spinal cord injury patients by promoting neuroplasticity.

Who is the study for?

This trial is for adults aged 18-75 with a spinal cord injury that happened over a year ago. They must be able to move their legs voluntarily and take one step without help. The injury should be between the C2 and T12 levels of the spine, not getting worse over time. People with diabetes, severe illnesses, allergies to caffeine or NSAIDs, pregnant women, or those with seizure disorders can't join.

What is being tested?

The study tests if low oxygen therapy (LOT) combined with an adenosine A2a receptor blocker called Istradefylline improves walking in people after spinal cord injuries. LOT may boost nerve pathway strength but could be less effective due to increased adenosine; this trial checks if blocking adenosine helps recovery.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information but generally could include discomfort from low oxygen therapy and typical drug-related reactions such as nausea, headache, or allergic responses specific to Istradefylline.

Eligibility Criteria

Inclusion Criteria

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

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My spinal injury is between my neck and upper back and is not getting worse.

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I can walk up a step without help.

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I can move my legs on my own.

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My injury occurred over a year ago.

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I can move my legs on my own.

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I can walk up a step without help.

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My spinal injury is between my neck and upper back and is not getting worse.

Exclusion Criteria

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

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I do not have any severe illnesses like heart disease or unhealed wounds.

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I have diabetes.

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I have cirrhosis.

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I am currently receiving physical therapy.

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I have a history of seizures, brain injury, or epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 day after last treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 1 day after last treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 day after last treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pre-Treatment Walking Speed

Walking Speed Post-Treatment 1

Walking Speed Post-Treatment 2

+1 more

Secondary study objectives

Ankle Strength Post-Treatment 1

Ankle Strength Post-Treatment 2

Ankle Strength Post-Treatment 3

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Istradefylline+low oxygen trainingExperimental Treatment2 Interventions

Drug: Nourianz Other Names: KW6002, Istradefylline Participants enrolled in this study arm will ingest a 20mg tablet/day containing istradefylline starting 14 days prior to the first low oxygen therapy and continuing for 14 additional days. Participants will consume a total of 28 istradefylline tablets. Other: low oxygen training Other Names: therapeutic intermittent hypoxia, acute intermittent hypoxia Participants will breathe 15 episodes/session of acute low oxygen via an automated air generator system (4 sessions/week x 2 weeks). During the 90-second episodes of low oxygen, air concentrations will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.10±0.02 (hypoxia) with 60-second room-air intervals (FIO2 0.21±0.02). Throughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored. We also will assess for changes in sleep quality and pain level.

Group II: Placebo+low oxygen trainingActive Control1 Intervention

This is a placebo counterpart to the istradefylline drug. Participants enrolled in this study arm will ingest a 20mg placebo tablet/day containing dextrose starting 14 days prior to the first low oxygen therapy (LOT) and continuing for 14 additional days. Participants will consume a total of 28 placebo tablets. Other: low oxygen training Other Names: therapeutic intermittent hypoxia, acute intermittent hypoxia Participants will breathe 15 episodes/session of acute low oxygen via an automated air generator system (4 sessions/week x 2 weeks). During the 90-second episodes of low oxygen, air concentrations will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.10±0.02 (hypoxia) with 60-second room-air intervals (FIO2 0.21±0.02). Throughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored. We also will assess for changes in sleep quality and pain level.

Group III: Istradefylline+SHAMActive Control1 Intervention

Drug: Nourianz Other Names: KW6002, Istradefylline This is a SHAM counterpart to low oxygen therapy. Participants enrolled in this study arm will ingest a 20mg tablet/day containing istradefylline starting 14 days prior to the first SHAM therapy and continuing for 14 additional days. Participants will consume a total of 28 istradefylline tablets. Participants will breathe 15 episodes/session of SHAM via an automated air generator system (4 sessions/week x 2 weeks). The system will fill reservoir bags attached to a non-rebreathing face mask. During the 90-second episodes of SHAM, air concentrations will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.21±0.02 (normoxia) with 60-second room-air intervals (FIO2 0.21±0.02). Throughout experimentation, blood pressure, respiratory rate, and heart rate will be monitored. We also will assess for changes in sleep quality and pain level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Istradefylline

2014

Completed Phase 3

~1120

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Spinal Cord Injury (SCI) often aim to enhance neural plasticity and functional recovery. Istradefylline, an adenosine 2a receptor antagonist, works by blocking the adenosine receptors that can accumulate and potentially inhibit neural recovery following SCI. This mechanism is crucial as it helps to mitigate the negative effects of excess adenosine, thereby promoting better outcomes in motor function and mobility. Other treatments, such as low oxygen therapy (LOT), trigger spinal plasticity by creating a hypoxic environment that stimulates neural pathways. Combining these approaches can significantly improve walking ability and overall functional recovery in SCI patients, highlighting the importance of targeting specific molecular pathways to enhance rehabilitation outcomes.

Theophylline-induced respiratory recovery following cervical spinal cord hemisection is augmented by serotonin 2 receptor stimulation.