Overview

This Phase II clinical trial protocol will provide evidence as to whether IN insulin is efficacious in reducing symptoms in people seeking care for mild TBI (concussion).

Eligibility

Inclusion Criteria:

• Subject has presented to a clinic/ER reporting an acute head injury (e.g., a closed head injury or blunt TBI) and presents with at least two symptoms of TBI, as defined by the listed symptoms on the Post-Concussion Symptom Scale (PCSS)
• Subject is considered high risk for persistent post-concussion symptoms using the post-concussion symptom (PoCS) clinical decision rule
• Subject is between ≥18 and ≤65 years of age
• Treatment can be initiated within 5-14 days after injury, inclusive
• Subject must be proficient in speaking English in order to comply with instructions and measures for the study
• Subject must be able to consent
• Female subjects of childbearing potential must have a negative pregnancy test at the baseline visit and be willing to use a medically acceptable contraceptive method for the duration of the study

Exclusion Criteria:

• Subject's concussion or TBI resulted in loss of consciousness of \> 30 minutes
• Subject has evidence of acute intracranial hemorrhage at screening
• Subjects has received an intranasal vaccine within 2 weeks of the date of their baseline visit
• 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, including findings of an abnormal nasopharyngeal exam that could interfere with intranasal administration as judged by the PI, e.g., inflammation, erythema, bleeding, atrophy, septal perforation, mucosal erosion, localized infection or ulceration, polyposis.
• 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
• Subject has evidence of blast injury, electrocution injury, or significant multisystem trauma associated with the mTBI, including significant nasal trauma
• Subject has participated in a clinical trial investigation (drug or device) within 3 months of this study.
• Subject has an insulin allergy
• Subject is taking insulin for Type I or Type II diabetes
• Subject is pregnant or breast feeding
• Subjects with nasal piercings or any physical finding in the nose that, in the opinion of the PI, would be likely to interfere with successful completion of dosing