NCT07521371Enrolling by invitation
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)
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 12 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Healing Hope International
- Diseases
- Autism
- NCT number
- NCT07521371
What you commit to
- Study type: Observational
- Planned participants: 12
- From 1 Jun 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of investigational drugs or participation in an interventional clinical trial within 30 days prior to enrollment
Other illness
- 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
- Any condition that would prevent reliable participation in study assessments, including inability of caregiver to complete questionnaires
Who the study is looking for
- 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
Age in the registry: 4 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Healing Hope International Coordinator of this site? Confirm its status | Spring | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.