Could a nasal spray help spinal cord injury? new safety trial begins
NCT ID NCT07384052
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This early-stage study is checking if insulin nasal spray is safe for people with spinal cord injury. Up to 12 adults who had an injury at least 4 months ago will use the spray or a placebo daily for up to 24 days. Researchers will monitor side effects and see if virtual training works for this approach.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 84 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Subject is ≥18 and \<85 years of age 2. Subject has sustained a traumatic or non-traumatic spinal cord injury with American Spinal Injury Association (ASIA) rating A, B, C or D, complete or incomplete 3. Subject sustained spinal cord injury at least 4 months before baseline visit 4. Female subjects must have either: (1) a negative pregnancy test at the screening and treatment visits OR (2) be at least 2 years post-menopausal / surgically sterile 5. The subject must be proficient in English in order to comply with instructions and measures for the study 6. Subject is able to prepare and administer the study drug as outlined in the protocol or has a carer who is available to do so for the duration of the study 7. Subject can provide written informed consent 8. Subject has been on a stable regimen of medications for at least 30 days from baseline visit Exclusion Criteria: 1. Subject is dependent on a ventilator or has a patent tracheostomy site 2. Subject has recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a sudden rise in systolic BP greater than 20 mmHg or diastolic BP greater than 10 mmHg without rise in heart rate and accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, or blurry vision 3. Subject has medical history and/or clinically determined disorders: chronic sinusitis, previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies 4. Subject has history of any of the following: active and significant central nervous system, psychiatric illness, pulmonary, or cardiovascular disorders or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator 5. Subject has participated in a clinical trial investigation within 3 months of this study 6. Subject has a history of allergy, hypersensitivity, or other significant adverse reaction to insulin 7. Subject is taking insulin for Type I or Type II diabetes 8. Subject is pregnant or breast feeding 9. Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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HealthPartners Neuroscience Center
RECRUITINGSaint Paul, Minnesota, 55130, United States
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Other studies related to the condition(s) this trial covers.
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