Istradefylline + Low Oxygen Therapy for Spinal Cord Injury

Overseen By William Muter

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Randy Trumbower, PT, PhD

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Randy Trumbower, PT, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 75 years old.

Medical clearance to participate

You had a significant injury more than 12 months ago.

Exclusion Criteria

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

You are allergic to caffeine or non-steroidal anti-inflammatory drugs (NSAIDs), or these substances make you feel unwell.

I have diabetes.

Treatment Details

Interventions

• Istradefylline (Adenosine A2a Receptor Antagonist)
• Low Oxygen Therapy (Device)

Trial Overview 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.

Participant Groups

Group I: Istradefylline+low oxygen training Experimental Treatment 2 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 training Active Control 1 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+SHAM Active Control 1 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.

Istradefylline is already approved in Japan for the following indications:

Approved in Japan as Nouriast for:

• Parkinson's disease

Who Is Running the Clinical Trial?

Randy Trumbower, PT, PhD

Lead Sponsor

Trials

1

Recruited

40+