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

ENROLLING BY INVITATION

NCT07521371

Sponsor: Healing Hope International

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.

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

Key Details

Gender

All

Age Range

4 Years - 21 Years

Study Type

OBSERVATIONAL

Enrollment

12

Start Date

2026-06-01

Completion Date

2030-01-30

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Autism Spectrum Disorder Autism Spectrum Disorder (ASD)Autism Spectrum Disorder High-Functioning Autism Spectrum Disorder With Absence of Functional Language Autism Spectrum Disorder With Impaired Functional Language Autistic Disorder of Childhood Onset With Full Syndrome Autistic Disorders Spectrum Autistic Disorder Autistic Disorder in Children and Adolescents Neurodevelopmental Disorders Neurodevelopmental Disorders (NDD)Neurodevelopmental Disorders and Developmental Abnormalities

Locations (1)

Healing Hope International

Spring, Texas, United States

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