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

Обзор

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.

Вмешательства

• Препарат Regular Insulin
  Administered Intranasally at 76 IU
• Другое 0.9 % Normal Saline
  Placebo Control

Первичные конечные точки

• Safety measured by number of serious adverse events (SAE) and adverse events (AE) [Срок оценки: 3 weeks]

Вторичные конечные точки (5)

• Treatment adherence as assessed by participant Daily Drug Diaries [Срок оценки: 3 weeks]
• Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist [Срок оценки: Baseline Visit]
• Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey [Срок оценки: Baseline]
• Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist [Срок оценки: Screening Visit]
• Acceptability of Blood Spot Procedure, as measured by a Blood Spot Procedure Post-Training Acceptability Survey [Срок оценки: Screening Visit]

Критерии участия

Критерии включения

• 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
• 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
• Subject can provide written informed consent
• Subject has been on a stable regimen of medications for at least 30 days from baseline visit

Критерии исключения

• Subject is dependent on a ventilator or has a patent tracheostomy site
• Subject has recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a sudden rise in systolic BP greater than 20 mmHg or diastolic BP greater than 10 mmHg without rise in heart rate and accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, or blurry vision
• 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
• 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 participated in a clinical trial investigation within 3 months of this study
• Subject has a history of allergy, hypersensitivity, or other significant adverse reaction to insulin
• Subject is taking insulin for Type I or Type II diabetes
• Subject is pregnant or breast feeding
• Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• HealthPartners Neuroscience Center — Saint Paul

Идентификаторы

NCT: NCT07384052 · A22-210-01 · CDMRP-SC220220

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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