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

Study acronym: INI-SCI
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2026 → Dec 2026
See other at-risk trials from HealthPartners Institute

Record History

  1. Primary completion pushed from Aug 2026 to Dec 2026 Completion pushed from Sep 2026 to Jan 2027 · Eligibility criteria expanded, about 17 words · Secondary endpoints: details revised at 1 of 5 entries · 1 more Show 4 more changesShow less
    • Completion pushed from Sep 2026 to Jan 2027
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site contact updated
  2. Start date changed from estimate of Feb 2026 to Feb 20, 2026v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07384052
Lead Sponsor HealthPartners Institute
Collaborators: Uniformed Services University of the Health Sciences, Congressionally Directed Medical Research Programs
Conditions Spinal Cord Injury
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov