Phase 2 Autism Spectrum Disorder Trial, Recruiting NCT05754073 Sponsor: Elizabeth Austen Lawson Condition: Autism Spectrum Disorder
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Phase 2 Autism Spectrum Disorder Trial, Recruiting

NCT05754073
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 6 and 18 years old at the time of joining the study
  • Your body weight (BMI) is at or above the 5th percentile for your age
  • You have been diagnosed with Autism Spectrum Disorder (ASD) by a specialist
  • A parent or guardian is available to give permission for you to take part

Who may not be able to join:

  • You have certain genetic conditions such as Fragile X syndrome, tuberous sclerosis, Williams syndrome, Angelman syndrome, Noonan syndrome, or other similar conditions that affect the heart or bone density
  • You have another health condition that may cause low bone density, such as a hormonal imbalance (confirm with trial site)
  • You take certain medications that can affect bone health, such as some anti-seizure drugs (like Phenytoin or Phenobarbital), steroid tablets taken by mouth, or a hormonal contraceptive injection called Depo-Provera (not including calcium or vitamin D supplements)
  • You have low sodium levels in your blood (confirm with trial site)
  • Your liver function blood test results are more than three times higher than the normal range
  • Your kidneys are not filtering blood well enough, based on a specific blood test result (confirm with trial site)
  • You have had a problem with substance or drug misuse in the last 6 months
  • You have a history of serious heart problems, such as coronary artery disease, heart failure, irregular heartbeat, or an abnormal heart rhythm reading on an ECG
  • You have had active seizures in the 6 months before joining the study
  • You are pregnant, breastfeeding, or are sexually active and are not willing to use contraception
  • You have received oxytocin (OXT) treatment within the 2 months before joining the study
  • You are not able to cooperate with taking medication, having blood drawn, or having scans done, even with extra support and training
  • Your caregiver is unable to speak English, cannot regularly attend study visits, or is unable to follow the study requirements
  • You have any other serious illness, condition, medication, or medical device that the study doctor believes could interfere with the study or affect your safety

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Elizabeth A Lawson, MD, Neuroendocrine Unit Massachusetts General Hospital

Phone: 434-924-9141

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Elizabeth Austen Lawson
Registry
ClinicalTrials.gov
Start date
1 August 2023
Est. completion
31 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Difference between IN OXT vs placebo in 12-month change in whole body less head BMD Z-scores.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov