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New treatment option for Autism Spectrum Disorder
Official title Oxytocin Effects on Bone in Children With Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT05754073
What this study is testing
What is 1. Intranasal oxytocin spray?
1. Intranasal oxytocin spray is an investigational medicine, given as an once-daily, being studied as a potential treatment for autism spectrum disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- Ages 6 to 18 years old at Randomization
- BMI greater than or equal to the 5th percentile
- Expert clinical diagnosis of ASD
- Availability of parent/guardian to provide informed consent
You likely can't join if
- Fragile X, tuberous sclerosis, William's syndrome, Angelman's syndrome, Noonan syndrome, and other single gene defects that are syndromic and affect...
- Other conditions that may contribute to low bone density (e.g., hypogonadism)
- Medications that may impact bone other than calcium or vitamin D supplementation, other than calcium or vitamin D supplementation, such as specific...
- Hyponatremia
- Liver enzymes (AST, ALT, and Bilirubin) more than three times the upper limit of the normal range
- Estimated glomerular filtration rate (eGFR) less than 60
See the full eligibility criteria
- Ages 6 to 18 years old at Randomization
- BMI greater than or equal to the 5th percentile
- Expert clinical diagnosis of ASD
- Availability of parent/guardian to provide informed consent
- Fragile X, tuberous sclerosis, William's syndrome, Angelman's syndrome, Noonan syndrome, and other single gene defects that are syndromic and affect heart or bone density
- Other conditions that may contribute to low bone density (e.g., hypogonadism)
- Medications that may impact bone other than calcium or vitamin D supplementation, other than calcium or vitamin D supplementation, such as specific anti-seizure medications (Phenytoin, Phenobarbital), oral...
- Hyponatremia
- Liver enzymes (AST, ALT, and Bilirubin) more than three times the upper limit of the normal range
- Estimated glomerular filtration rate (eGFR) less than 60
- Substance use disorder within the last 6 months
- History of known coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT (QTc greater than or equal to 480 msec)
- Active seizures within 6 months preceding the Screening visit or the Baseline visit
- people who are pregnant, lactating, or who refuse contraception if sexually active
- people who have had previous treatment with OXT (within 2 months of Randomization)
- people who are not able to cooperate with medication administration, blood drawing, or imaging procedures despite behavior training
- Caregivers who are unable to speak English, be consistently present at study visits to report on symptoms or, per the judgement of the data collection team, are unable to comply with the protocol
- Any significant illness, condition, medication, or medical device that the Investigator determines could interfere with study participation and impact data collection or subject safety
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.