An observational study in Autism Spectrum Disorder, Autism Spectrum Disorder (ASD) and Autism Spectrum Disorder High-Functioning, sponsored by Healing Hope International. Enrolling by invitation at 1 site in United States. Open to participants aged 4 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Healing Hope International · Observational
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.
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 12 is below the median of 101 across 189 observational studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Healing Hope International is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Baseline to 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months
Plan to share: 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.
Start is estimated for Jun 2026; primary completion for Dec 2028, 30 months later.
Of 57 non-industry observational studies under Autistic Disorder, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 144. This study's planned 30 months is below that.
Counting every sponsor, half of 65 studies reached it within 43 months; a quarter within 20 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
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