NCT07384052 Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury
| NCT ID | NCT07384052 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | HealthPartners Institute |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-02-20 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-02-20 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to find out whether insulin, a drug approved by the FDA for the treatment of diabetes mellitus, is safe when administered as a nasal spray (intranasally) to people who have experienced a spinal cord injury. While insulin nasal spray has been shown to be safe in many patient populations, it has not yet been studied in people with spinal cord injury. This study would be the first step to developing insulin nasal spray as a treatment for spinal cord injury in the future. This study is recruiting up to 12 individuals who have experienced a spinal cord injury at least 4 months ago to administer either 76 IU insulin nasal spray or a placebo (inactive nasal spray) at home every day for up to 24 days. Participants will be asked questions about their health and symptoms related their spinal cord injury, and will have their blood collected throughout the study. Participants who are unable to administer the medication independently must have a study partner in order to participate.
Eligibility Criteria
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
Contact & Investigator
Leah R Hanson, PhD
PRINCIPAL INVESTIGATOR
HealthPartners Institute
Frequently Asked Questions
Who can join the NCT07384052 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 84 Years, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07384052 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07384052 currently recruiting?
Yes, NCT07384052 is actively recruiting participants. Contact the research team at Meghan.E.Obrien@HealthPartners.com for enrollment information.
Where is the NCT07384052 trial being conducted?
This trial is being conducted at Saint Paul, United States.
Who is sponsoring the NCT07384052 clinical trial?
NCT07384052 is sponsored by HealthPartners Institute. The principal investigator is Leah R Hanson, PhD at HealthPartners Institute. The trial plans to enroll 12 participants.