Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Autism Spectrum Disorder and Bone Health, sponsored by Elizabeth Austen Lawson.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT05754073 shows while recruiting
NCT05754073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (29% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05754073's enrollment target sits among peer trials
96 80th of 224 higher than 144 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder
RECRUITING · Phase 2
-
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial
RECRUITING · Phase 2
-
Early Treatment of Language Impairment in Young Children With Autism Spectrum Disorder With Leucovorin Calcium
RECRUITING · Phase 2
-
Optimizing Outcomes for Young Autistic Children
RECRUITING · Phase 2
-
Trial of Zolpidem for Sleep in Children With Autism
RECRUITING · Phase 2
-
Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With ASD
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03401762 · 96 participants · NA
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
- NCT03471260 · 96 participants · Phase 1
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
- NCT03549559 · 96 participants · NA
Imaging Histone Deacetylase in the Heart
- NCT03841058 · 96 participants · Phase 2
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI