Trials / Enrolling By Invitation

Enrolling By InvitationNCT07521371

Intranasal Insulin for Autism Spectrum Disorder in Children and Young Adults Aged 4 to 21 Years

Observational Study of Intranasal Insulin Delivery in Autism Spectrum Disorder Ages 4 to 21 Years (INS-AUT)

Status: Enrolling By Invitation
Phase: —
Study type: Observational
Enrollment: 12 (estimated)

Sponsor: Healing Hope International · Academic / Other
Sex: All
Age: 4 Years – 21 Years
Healthy volunteers: Not accepted

Summary

This observational study evaluates the real-world use of intranasal insulin in children and young adults with autism spectrum disorder (ASD) utilizing the ViaNase™ device developed by Kurve Therapeutics. Intranasal insulin represents an off label use of an FDA approved medication and is prescribed by participants' treating healthcare providers as part of routine clinical care. Insulin is a hormone involved in cerebral energy metabolism and may play a role in cognitive processes such as learning, memory, and behavior. Emerging research suggests that intranasal delivery using specialized delivery systems such as ViaNase™ may facilitate transport along olfactory and trigeminal pathways, potentially allowing insulin to reach central nervous system targets. This delivery approach has been associated in early studies with changes in social communication and functional outcomes in individuals with neurodevelopmental conditions. This study will follow approximately 12 participants between the ages of 4 and 21 years who are already receiving, or planning to receive, intranasal insulin as part of their standard clinical care using the ViaNase™ device. This is a non-interventional observational study; no treatment is assigned or provided by the study team. Participants will be monitored over an approximate 6-month period for changes in autism-related symptoms, including social interaction, communication, repetitive behaviors, and overall functional development. In addition, safety data will be collected, including tolerability and any reported adverse events. The primary objective of this study is to generate real-world evidence to better characterize the safety profile and potential functional effects of intranasal insulin delivered via ViaNase™ in individuals with ASD, and to inform the design of future controlled clinical investigations.

Detailed description

This is a prospective, single arm observational cohort study designed to evaluate the real world use of intranasal insulin in children and young adults diagnosed with autism spectrum disorder (ASD). Intranasal insulin represents an off label route of administration of an FDA approved medication. In this study, insulin is prescribed and managed independently by participants' treating healthcare providers as part of routine clinical care. The study does not assign, provide, or direct treatment, dosing, or route of administration. All clinical decisions are made outside of the study. The purpose of this study is to collect real world evidence (RWE) on the safety, tolerability, and potential clinical associations of intranasal insulin use in individuals with ASD. Insulin signaling in the central nervous system has been associated with neurodevelopment, synaptic plasticity, and cognitive function. Intranasal delivery may facilitate transport to the brain via olfactory and trigeminal pathways, and early studies suggest possible associations with changes in social communication and behavioral outcomes. Approximately 12 participants ages 4 to 21 years who are receiving or planning to receive intranasal insulin as part of their clinical care will be enrolled and followed prospectively for approximately 6 months. Data will be collected at baseline, during ongoing use, and at follow-up intervals. Outcome measures will include caregiver reported assessments of social communication, behavior, adaptive functioning, and overall developmental progress. Safety monitoring will include documentation of adverse events, tolerability, and any clinically relevant observations reported by caregivers or healthcare providers. This study is observational in nature and does not involve the prospective assignment of any intervention. The study team does not provide insulin or any delivery device. Participation in this study does not influence clinical care. The goal of this study is to generate real world data to better understand the safety profile and potential clinical associations of intranasal insulin use in ASD and to inform future clinical research.

Conditions

Timeline

Start date: 2026-06-01
Primary completion: 2028-12-31
Completion: 2030-01-30
First posted: 2026-04-09
Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07521371. Inclusion in this directory is not an endorsement.