By InvitationNot Applicable

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

United States12 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range4 Years – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 4 to 21 years * Clinical diagnosis of autism spectrum disorder (ASD) documented by a qualified healthcare provider * Currently using or planning to use intranasal insulin as prescribed by a treating healthcare provider as part of routine clinical care * Stable medical and behavioral therapy regimen for at least 4 weeks prior to baseline (if applicable) * Caregiver or parent/guardian able to provide informed consent and complete study related assessments * Willingness to participate in observational data collection over approximately 6 months Exclusion Criteria: * Known diagnosis of diabetes mellitus requiring insulin for glycemic control * History of recurrent hypoglycemia or clinically significant risk of hypoglycemia * Known hypersensitivity or adverse reaction to insulin * Significant uncontrolled medical conditions that, in the opinion of the investigator, would interfere with participation or data interpretation * Use of investigational drugs or participation in an interventional clinical trial within 30 days prior to enrollment * Any condition that would prevent reliable participation in study assessments, including inability of caregiver to complete questionnaires

What they're measuring

Change in Social Responsiveness Scale, Second Edition (SRS-2) Total Score

Timeframe: Baseline to 6 months

Trial details

NCT IDNCT07521371

SponsorHealing Hope International

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31