Autism Spectrum DisorderIN-INS-AUTNCT07521371
Intranasal Insulin for Autism Spectrum Disorder in Children and Young Adults Aged 4 to 21 Years
An observational study of Autism Spectrum Disorder and Autism Spectrum Disorder (ASD), run by Healing Hope International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), Autism Spectrum Disorder High-Functioning
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 30 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Observational Study of Intranasal Insulin Delivery in Autism Spectrum Disorder Ages 4 to 21 Years (INS-AUT)
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.
Read more
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.
Read the detailed description
This is a prospective, single arm observational cohort study designed to evaluate the real world use of intranasal insulin in children and young adults diagnosed with autism spectrum disorder (ASD).
Intranasal insulin represents an off label route of administration of an FDA approved medication. In this study, insulin is prescribed and managed independently by participants' treating healthcare providers as part of routine clinical care. The study does not assign, provide, or direct treatment, dosing, or route of administration. All clinical decisions are made outside of the study.
The purpose of this study is to collect real world evidence (RWE) on the safety, tolerability, and potential clinical associations of intranasal insulin use in individuals with ASD. Insulin signaling in the central nervous system has been associated with neurodevelopment, synaptic plasticity, and cognitive function. Intranasal delivery may facilitate transport to the brain via olfactory and trigeminal pathways, and early studies suggest possible associations with changes in social communication and behavioral outcomes.
Approximately 12 participants ages 4 to 21 years who are receiving or planning to receive intranasal insulin as part of their clinical care will be enrolled and followed prospectively for approximately 6 months. Data will be collected at baseline, during ongoing use, and at follow-up intervals.
Outcome measures will include caregiver reported assessments of social communication, behavior, adaptive functioning, and overall developmental progress. Safety monitoring will include documentation of adverse events, tolerability, and any clinically relevant observations reported by caregivers or healthcare providers.
This study is observational in nature and does not involve the prospective assignment of any intervention. The study team does not provide insulin or any delivery device. Participation in this study does not influence clinical care.
The goal of this study is to generate real world data to better understand the safety profile and potential clinical associations of intranasal insulin use in ASD and to inform future clinical research.
- 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
- 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
- Medical subject headings
- Autism Spectrum Disorder, Child Development Disorders, Pervasive, Autistic Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (4)
Caregiver Global Impression of Change (CGI-C)
Caregivers will report perceived overall changes in the participant's condition over time using a standardized global impression scale.
Measured: Up to 6 months
Change in Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
The Vineland-3 assesses adaptive functioning across communication, daily living skills, and socialization domains. Changes in standard scores over time will be evaluated to assess functional development.
Measured: Baseline to 6 months
Incidence of Adverse Events and Tolerability
Safety will be assessed by collecting reported adverse events, including nasal irritation, hypoglycemia symptoms, and other clinically relevant observations during routine use of intranasal insulin.
Measured: Baseline to 6 months
Change in Repetitive Behaviors and Social Communication (Caregiver Reported)
Caregiver reported changes in repetitive behaviors, communication, and social interaction will be tracked using structured questionnaires or standardized reporting tools.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healing Hope International
- Sponsor type
- University, hospital or other
- Collaborators
- Kurve Technology Inc.
- Responsible party
- Sponsor
- Investigators
- Glen Cronett, PhD/MD, Principal investigator, CMO Kurve Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521371
- Sponsor's protocol ID
- HHI-INS-AUT-OBS-2026-001
- Acronym
- IN-INS-AUT
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing is currently undecided. This observational study involves a small cohort and the collection of sensitive health information, including data from pediatric participants. Any future sharing of IPD will require strict de identification to protect participant privacy and will be subject to applicable regulatory requirements, institutional policies, and informed consent provisions. There is an intention to share aggregated study results through publications, presentations, and public platforms to contribute to scientific understanding and support future research. Consideration of IPD sharing may occur at a later stage following study completion, data validation, and evaluation of appropriate data use agreements and governance frameworks.
Publications
Rose D, Moreno RJ, Osman H, Rowland ME, Silverman J, Ciernia A, Ashwood P. Sex specific effects of adoptive Tregs transfer on the brain and periphery in maternal immune activation offspring rescuing immune dysregulation. J Neuroinflammation. 2026 Mar 12;23(1):133. doi: 10.1186/s12974-026-03739-w.
PubMed 41821031Zwanenburg RJ, Bocca G, Ruiter SA, Dillingh JH, Flapper BC, van den Heuvel ER, van Ravenswaaij-Arts CM. Is there an effect of intranasal insulin on development and behaviour in Phelan-McDermid syndrome? A randomized, double-blind, placebo-controlled trial. Eur J Hum Genet. 2016 Dec;24(12):1696-1701. doi: 10.1038/ejhg.2016.109. Epub 2016 Aug 31.
PubMed 27577546Gao 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.
PubMed 28190211Schmidt 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.
PubMed 18948358
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Intranasal Insulin Delivery in Autism Spectrum Disorder Ages 4 to 21 Years (INS-AUT)
- ClinicalTrials.gov ID
- NCT07521371
- Acronym / sponsor ID
- IN-INS-AUT / HHI-INS-AUT-OBS-2026-001
- 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
- Keywords
- intranasal insulin, Kurve nasal device, nose-to-brain delivery, autism spectrum disorder, ASD observational, neurodevelopmental, intranasal insulin autism, controlled particle dispersion
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Healing Hope InternationalUniversity, hospital or other
- Collaborators
- Kurve Technology Inc.
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single arm observational cohort study designed to evaluate the real world use of intranasal insulin in children and young adults diagnosed with autism spectrum disorder (ASD).
Intranasal insulin represents an off label route of administration of an FDA approved medication. In this study, insulin is prescribed and managed independently by participants' treating healthcare providers as part of routine clinical care. The study does not assign, provide, or direct treatment, dosing, or route of administration. All clinical decisions are made outside of the study.
The purpose of this study is to collect real world evidence (RWE) on the safety, tolerability, and potential clinical associations of intranasal insulin use in individuals with ASD. Insulin signaling in the central nervous system has been associated with neurodevelopment, synaptic plasticity, and cognitive function. Intranasal delivery may facilitate transport to the brain via olfactory and trigeminal pathways, and early studies suggest possible associations with changes in social communication and behavioral outcomes.
Approximately 12 participants ages 4 to 21 years who are receiving or planning to receive intranasal insulin as part of their clinical care will be enrolled and followed prospectively for approximately 6 months. Data will be collected at baseline, during ongoing use, and at follow-up intervals.
Outcome measures will include caregiver reported assessments of social communication, behavior, adaptive functioning, and overall developmental progress. Safety monitoring will include documentation of adverse events, tolerability, and any clinically relevant observations reported by caregivers or healthcare providers.
This study is observational in nature and does not involve the prospective assignment of any intervention. The study team does not provide insulin or any delivery device. Participation in this study does not influence clinical care.
The goal of this study is to generate real world data to better understand the safety profile and potential clinical associations of intranasal insulin use in ASD and to inform future clinical research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Social Responsiveness Scale, Second Edition (SRS-2) Total Score
Time frame: Baseline to 6 months
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.
4 secondary outcomes
Caregiver Global Impression of Change (CGI-C)
Time frame: Up to 6 months
Change in Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Time frame: Baseline to 6 months
Incidence of Adverse Events and Tolerability
Time frame: Baseline to 6 months
Change in Repetitive Behaviors and Social Communication (Caregiver Reported)
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 41821031Rose D, Moreno RJ, Osman H, Rowland ME, Silverman J, Ciernia A, Ashwood P. Sex specific effects of adoptive Tregs transfer on the brain and periphery in maternal immune activation offspring rescuing immune dysregulation. J Neuroinflammation. 2026 Mar 12;23(1):133. doi: 10.1186/s12974-026-03739-w.
- Background: PubMed 27577546Zwanenburg RJ, Bocca G, Ruiter SA, Dillingh JH, Flapper BC, van den Heuvel ER, van Ravenswaaij-Arts CM. Is there an effect of intranasal insulin on development and behaviour in Phelan-McDermid syndrome? A randomized, double-blind, placebo-controlled trial. Eur J Hum Genet. 2016 Dec;24(12):1696-1701. doi: 10.1038/ejhg.2016.109. Epub 2016 Aug 31.
- Background: PubMed 28190211Gao 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.
- Background: PubMed 18948358Schmidt 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.
- Kurve TherapeuticsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing is currently undecided. This observational study involves a small cohort and the collection of sensitive health information, including data from pediatric participants. Any future sharing of IPD will require strict de identification to protect participant privacy and will be subject to applicable regulatory requirements, institutional policies, and informed consent provisions. There is an intention to share aggregated study results through publications, presentations, and public platforms to contribute to scientific understanding and support future research. Consideration of IPD sharing may occur at a later stage following study completion, data validation, and evaluation of appropriate data use agreements and governance frameworks.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glen Cronett, PhD/MD principal investigator
CMO Kurve Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Autism Spectrum Disorder (ASD), run by Healing Hope International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social Responsiveness Scale, Second Edition (SRS-2) Total Score (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07521371, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.