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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 1 day after last treatment

Awards & highlights

Study Summary

This trial is investigating whether istradefylline, an adenosine 2a receptor antagonist, may improve walking ability in people with spinal cord injury by limiting the competing mechanisms of adenosine.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pre-Treatment Walking Speed

Walking Speed Post-Treatment 1

Walking Speed Post-Treatment 2

+1 more

Secondary outcome measures

Ankle Strength Post-Treatment 1

Ankle Strength Post-Treatment 2

Ankle Strength Post-Treatment 3

+9 more

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Randy Trumbower, PT, PhDLead Sponsor

Randy D Trumbower, PT, PhDPrincipal InvestigatorSpaulding Rehabilitation Hospital

5 Previous Clinical Trials

182 Total Patients Enrolled

Media Library

Istradefylline (Adenosine A2a Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05217498 — Phase 1 & 2

Spinal Cord Injury Research Study Groups: Placebo+low oxygen training, Istradefylline+SHAM, Istradefylline+low oxygen training

Spinal Cord Injury Clinical Trial 2023: Istradefylline Highlights & Side Effects. Trial Name: NCT05217498 — Phase 1 & 2

Istradefylline (Adenosine A2a Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05217498 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Why did researchers design this clinical trial?

"The primary endpoint of this clinical study will be changes in Walking Speed Post-Treatment 2, which will be measured within 1 day after the last treatment. Additionally, researchers will also track patients' progress in terms of Secondary outcomes like Walking Distance Post-Treatment 1 (6MWT distance in meters) and Pre-Treatment Walking Distance (measured 6MWT distance in meters) as well as Walking Distance Post-Treatment 2."

Answered by AI

Can octogenarians participate in this trial?

"This study is taking applications from adults aged 18-75."

Answered by AI

Are patients currently being sought for this clinical trial?

"This particular clinical trial, as evidenced by the date of its last edit on clinicaltrials.gov, is not currently looking for patients. However, there are nearly one thousand other trials that are presently enrolling candidates."

Answered by AI

Might I be eligible to take part in this research project?

"Up to 40 patients with spinal cord injuries, aged 18-75, may be accepted into this study. Other requirements for participants include: a lesion at or below C2 and above T12, motor-incomplete classification with visible leg movement, and the injury must have occurred more than 12 months ago. Patients must also be able to advance one step unassisted."

Answered by AI