Intranasal insulin for adults with spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.