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

Part of paid clinical trials in Spring, Texas.

Sponsor
Healing Hope International
Study ID
NCT07521371
Status
Enrolling By Invitation

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

Eligibility Criteria

Sex
ALL
Age
4 Years - 21 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Jan 30, 2030

Study Design

Enrollment
12 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in Social Responsiveness Scale, Second Edition (SRS-2) Total Score [ Time Frame: Baseline to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Healing Hope InternationalSpringTexas77386-

Find similar trials in Spring, TX

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Healing Hope International· Spring, TX

Related Studies