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

NCT07521371 | Enrolling By Invitation

• 1 other identifier: HHI-INS-AUT-OBS-2026-001
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

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 Disorders Spectrum; Autistic Disorder; Neurodevelopmental Disorders; Neurodevelopmental Disorders (NDD); Autistic Disorder of Childhood Onset With Full Syndrome; Autistic Disorder in Children and Adolescents; Neurodevelopmental Disorders and Developmental Abnormalities

Keywords

intranasal insulin; Kurve nasal device; nose-to-brain delivery; autism spectrum disorder; ASD observational; neurodevelopmental; intranasal insulin autism; controlled particle dispersion; CPD nasal device; pediatric autism; autism children insulin; neurodevelopmental disorders; social communication autism; repetitive behaviors autism; intranasal delivery autism; observational study ASD insulin; brain insulin signaling; developmental delay insulin; nasal spray autism; ASD; real-world evidence; off-label; observational cohort

Outcome Measures

Primary Outcomes (1)

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

  The Social Responsiveness Scale, Second Edition (SRS-2) is a caregiver-reported measure of social communication and autism-related behaviors. Change in total score from baseline to approximately 6 months will be assessed to evaluate changes in social functioning over time in participants using intranasal insulin as part of routine clinical care.

  Baseline to 6 months

Secondary Outcomes (4)

• Caregiver Global Impression of Change (CGI-C)

  Up to 6 months

• Change in Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)

  Baseline to 6 months

• Incidence of Adverse Events and Tolerability

  Baseline to 6 months

• Change in Repetitive Behaviors and Social Communication (Caregiver Reported)

  Baseline to 6 months

Study Arms (1)

Intranasal Insulin Cohort

This single observational cohort includes approximately 12 children and young adults (ages 4 to 21 years) diagnosed with autism spectrum disorder (ASD) who are using or planning to use intranasal insulin as prescribed by their treating healthcare providers as part of routine clinical care. Intranasal insulin in this study represents off label use of an FDA approved medication. The study does not assign, provide, or direct treatment, dosing, or route of administration. All clinical decisions are made independently by the participant's healthcare provider. Participants are followed prospectively for approximately 6 months in a real world clinical setting. The exposure of interest is the use of intranasal insulin. Data collection includes assessments of safety and tolerability (including reported adverse events), as well as changes in autism-related outcomes such as social communication, behavior, adaptive functioning, and overall developmental status.

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study population includes approximately 12 children and young adults (ages 4 to 21 years) with a clinical diagnosis of autism spectrum disorder (ASD). Participants are individuals who are using or planning to use intranasal insulin as prescribed by their treating healthcare providers as part of routine clinical care. The population represents a real-world sample of individuals with ASD across a range of functional abilities and symptom severity. Caregivers are involved in reporting outcomes related to social communication, behavior, and adaptive functioning. Participants are followed prospectively for approximately 6 months in a non-interventional, observational setting.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Healing Hope International: lead
• Kurve Technology Inc.: collaborator

Study Sites (1)

Healing Hope International

Spring, Texas, 77386, United States

Location

Related Publications (4)

• Rose, D., Moreno, R.J., Osman, H. et al. Sex specific effects of adoptive Tregs transfer on the brain and periphery in maternal immune activation offspring rescuing immune dysregulation. J Neuroinflammation (2026). https://doi.org/10.1186/s12974-026-03739-w

  BACKGROUND

• Zwanenburg RJ,Bocca G,Ruiter SA,Dillingh JH,Flapper BC,van den Heuvel ER,van Ravenswaaij-Arts CM

  BACKGROUND

• Gao B, Wang S, Wang Y, Shen D, Xue S, Chen C, Cui H, Song C. Low diversity, activity, and density of transposable elements in five avian genomes. Funct Integr Genomics. 2017 Jul;17(4):427-439. doi: 10.1007/s10142-017-0545-0. Epub 2017 Feb 11.

  PMID: 28190211 BACKGROUND

• Schmidt H, Kern W, Giese R, Hallschmid M, Enders A. Intranasal insulin to improve developmental delay in children with 22q13 deletion syndrome: an exploratory clinical trial. J Med Genet. 2009 Apr;46(4):217-22. doi: 10.1136/jmg.2008.062141. Epub 2008 Oct 23.

  PMID: 18948358 BACKGROUND

Related Links

• Kurve Therapeutics

MeSH Terms

Conditions

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Autistic Disorder; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Glen Cronett, PhD/MD

  CMO Kurve Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 30, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)