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

What Was Tested

The trial (phase 1) is built around Insulin (regular human).

This study would be the first step to developing insulin nasal spray as a treatment for spinal cord injury in the future.

It had two arms (groups): Intranasal Insulin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

12 planned participants were the target.

It was open to people of any sex aged from 18 years up to 84 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subject is ≥18 and \<85 years of age. 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. Subject sustained spinal cord injury at least 4 months before baseline visit. 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. The subject must be proficient in English in order to comply with instructions and measures for the study.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: subject is dependent on a ventilator or has a patent tracheostomy site; subject has participated in a clinical trial investigation within 3 months of this study; subject is taking insulin for type i or type ii diabetes.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-02-20 with completion listed for 2026-12.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Safety measured by number of serious adverse events (SAE) and adverse events (AE) (time frame: 3 weeks).

It also tracked 5 secondary outcomes, for example Treatment adherence as assessed by participant Daily Drug Diaries, Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist, Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey, Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist and Acceptability of Blood Spot Procedure, as measured by a Blood Spot Procedure Post-Training Acceptability Survey.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 12 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.