Intranasal insulin for adults with spinal cord injury
Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury
This trial will test whether a daily insulin nasal spray is safe for adults who had a spinal cord injury at least four months ago.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | HealthPartners Institute Academic / other |
| Locations | 1 site (Saint Paul, Minnesota) |
| Trial ID | NCT07384052 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial will enroll up to 12 adults (age 18–84) with traumatic or non‑traumatic spinal cord injury at least four months after injury and randomize them to 76 IU intranasal regular insulin or placebo given at home daily for up to 24 days. Participants will complete health and symptom questionnaires and have blood drawn at scheduled visits to monitor safety, tolerability, and any adverse events, and those unable to self‑administer will require a study partner. The primary goal is to determine safety and feasibility rather than benefit, with close monitoring for hypoglycemia and other potential risks. Results will inform whether larger trials to test effectiveness are warranted.
Who should consider this trial
Good fit: Ideal candidates are adults 18–84 with a traumatic or non‑traumatic spinal cord injury (ASIA A–D) sustained at least four months earlier who can administer the nasal spray themselves or have a carer to help and can attend required site visits.
Not a fit: Patients who are ventilator‑dependent, have a tracheostomy, are pregnant, or are otherwise medically unstable are unlikely to benefit from participation in this safety-focused trial.
Why it matters
Potential benefit: If shown to be safe, intranasal insulin could offer a convenient, noninvasive approach to explore for improving neurological recovery after spinal cord injury.
How similar studies have performed: Intranasal insulin has been shown to be safe in several other populations, but it has not previously been tested in people with spinal cord injury.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint Paul, Minnesota
- HealthPartners Neuroscience Center — Saint Paul, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Leah R Hanson, PhD — HealthPartners Institute
- Study coordinator: Meghan E O'Brien, MPH
- Email: Meghan.E.Obrien@HealthPartners.com
- Phone: 651-495-6363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.