Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury

Part of paid clinical trials in Saint Paul, Minnesota.

Sponsor
HealthPartners Institute
Study ID
NCT07384052
Phase
PHASE1
Status
Recruiting
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Conditions

  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • Regular Insulin — DRUG
    Administered Intranasally at 76 IU
  • 0.9 % Normal Saline — OTHER
    Placebo Control

Study Details

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.

Key Dates

Start date
Feb 20, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Intranasal Insulin
    Regular Insulin (Novolin-R) 76 international units per day administered as 38 IU in one nostril twice daily (alternating nostrils) for 21+/-3 days
  • Placebo Comparator: Placebo
    0.9% sodium chloride in one nostril twice daily (alternating nostrils) for 21+/- days

Primary Outcome Measure

Safety measured by number of serious adverse events (SAE) and adverse events (AE) [ Time Frame: 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
HealthPartners Neuroscience CenterSaint PaulMinnesota55130
Meghan E O'Brien, MPH
[email protected]
651-495-6363
Bethany K Crouse, PhD
[email protected]
Leah R Hanson, PhD (PRINCIPAL_INVESTIGATOR)

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HealthPartners Neuroscience Center· Saint Paul, MN

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