Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury
Trial Parameters
Brief Summary
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.
Eligibility Criteria
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