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New drug aims to supercharge walking recovery after spinal cord injury

NCT ID NCT05217498

Disease control Sponsor: Randy Trumbower, PT, PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a drug called istradefylline can boost the walking improvements seen with low-oxygen therapy in people with chronic, incomplete spinal cord injury. About 40 adults aged 18-75 with injuries at least one year old will receive the drug or a placebo before walking practice. The goal is to see if blocking adenosine can make walking gains last longer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2027

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. age 18 and 75 years (the latter to reduce the likelihood of heart disease) medical clearance to participate 2. lesion at or below C2 and above T12 with non-progressive etiology 3. classified as motor-incomplete with visible volitional leg movement 4. injury greater than 12 months 5. ability to advance one step overground without human assistance Exclusion Criteria: 1. Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications) 2. Pregnant women because of the unknown effects of AIH on pregnant women and fetus 3. History of seizures, brain injury, and/or epilepsy 4. Undergoing concurrent physical therapy 5. Diabetes 6. Cirrhosis Caffeine and/or NSAID allergies or intolerances

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Conditions

The condition(s) this trial relates to.

spinal cord disorder spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelopathy Spinal cord injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Spaulding Rehabilitation Hospital

    Cambridge, Massachusetts, 02138, United States

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