Health TrialsbyHealthPanel

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

ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-84
SponsorHealthPartners Institute

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Regular Insulin

    Drug

    Administered Intranasally at 76 IU

  • 0.9 % Normal Saline

    Other intervention

    Placebo Control

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Intranasal InsulinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety measured by number of serious adverse events (SAE) and adverse events (AE)

Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment. AEs counts will include total count and will be stratified by severity.

Time frame
3 weeks

Secondary outcomes

1

Treatment adherence as assessed by participant Daily Drug Diaries

Number of doses successfully administered as reported by participants in their daily drug diaries

Time frame
3 weeks
2

Feasibility of virtual training as assessed by the Virtual Training Compliance Checklist

Average score on virtual training compliance checklist, both arms combined

Time frame
Baseline Visit
3

Acceptability of virtual training as assessed by the Virtual Training and Feasibility and Acceptability Survey

Total score on the Virtual Training Feasibility and Acceptability Survey, both arms combined

Time frame
Baseline
4

Feasibility of blood spot collection procedure as measured by a Blood Spot Procedure Compliance Checklist

Participants will be trained to perform a blood spot collection procedure independently. Feasibility will be measured by the average score on blood spot procedure compliance checklist, both arms combined

Time frame
Screening Visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HealthPartners Institute

Lead sponsor

Uniformed Services University of the Health Sciences

Collaborator

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
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