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NCT05754073 · ClinicalTrials.gov registry record · Phase 2
Oxytocin Effects on Bone in Children With Autism Spectrum Disorder
A Phase 2 study of Autism Spectrum Disorder and Bone Health, sponsored by Elizabeth Austen Lawson.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 2
- Study locations
NCT05754073 is a Phase 2 study of Autism Spectrum Disorder and Bone Health that is actively recruiting participants, run by Elizabeth Austen Lawson. The registered enrollment target is 96 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (29% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05754073, a Phase 2 study of Autism Spectrum Disorder and Bone Health, is actively recruiting participants, sponsored by Elizabeth Austen Lawson.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 2
- Study locations
Study Summary
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). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.
Conditions Studied
Interventions
- DRUG 1. Intranasal oxytocin spray
- DRUG 2. Intranasal placebo spray
- DRUG 3. Intranasal Oxytocin spray
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
Virginia
- University of Virginia Medical Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05754073
The ClinicalTrials.gov registry entry for NCT05754073 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (29% lower). The listed sponsor is Elizabeth Austen Lawson, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 3 interventions - of which 1. Intranasal oxytocin spray is the first listed.
NCT05754073 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Virginia.
Frequently Asked Questions
What is clinical trial NCT05754073 about?
NCT05754073 is a clinical study titled "Oxytocin Effects on Bone in Children With Autism Spectrum Disorder". 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-b...
What is the current status of trial NCT05754073?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2023-08-01. Estimated completion is 2028-08-31.
What conditions does trial NCT05754073 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Bone Health.
What interventions are being tested in trial NCT05754073?
The interventions under investigation include: 1. Intranasal oxytocin spray (DRUG), 2. Intranasal placebo spray (DRUG), 3. Intranasal Oxytocin spray (DRUG).
Who is sponsoring clinical trial NCT05754073?
This trial is sponsored by Elizabeth Austen Lawson, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05754073 being conducted?
This trial has 2 study locations across Massachusetts, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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