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NCT07521371

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

Enrolling by Invitation
Not specifiedAges 4–21Observational
Healing Hope International
~12 participants
Updated 2026-04-09 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Social Responsiveness Scale, Second Edition (SRS-2) Total Score
Measured over Baseline to 6 months

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
Autistic Disorders Spectrum
Autistic Disorder
Autistic Disorder in Children and Adolescents
Neurodevelopmental Disorders
Neurodevelopmental Disorders (NDD)
Neurodevelopmental Disorders and Developmental Abnormalities

Explore related trials

Autism Spectrum Disorder

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Glen Cronett, PhD/MD · PRINCIPAL_INVESTIGATOR · CMO Kurve Therapeutics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

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