Autism Spectrum Disorder Trial, Recruiting NCT06529380 Sponsor: The Hospital for Sick Children Condition: Autism Spectrum Disorder
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Autism Spectrum Disorder Trial, Recruiting

NCT06529380
Recruiting Not Applicable

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:

  • The child must be between 5 and 17 years old at the time of joining the study.
  • The child must have a formal diagnosis of Autism Spectrum Disorder (ASD) based on recognised diagnostic guidelines.
  • The child must have a history of repeatedly hurting themselves, as reported by a parent or carer and confirmed through a clinical assessment or previous medical records.
  • There must be a recognised risk that the child could seriously hurt themselves in the future.
  • The study team will check whether the child's self-injurious behaviour fits a specific pattern (called "automatically reinforced self-injurious behaviour subtype 2 or 3") based on information provided by the caregiver (confirm with trial site).
  • The child must have tried medical treatment for their self-injurious behaviour without sufficient improvement, or be ineligible for such treatment, for at least 6 months.
  • A parent, legal guardian, or caregiver must be fully informed about the study and willing and able to give written permission for the child to take part.
  • The family must be able to attend all required tests, appointments, and follow-up visits for 12 months after the study ends.

Who may not be able to join:

  • The child must not have had problems with substance misuse or dependence in the last 6 months (caffeine and nicotine are not included in this).
  • The child must not have any reason they cannot safely have an MRI scan.
  • The child must not have irregular heart rhythms, or significant heart, breathing, kidney, or hormone-related conditions that could make surgery risky.
  • The child must not be pregnant.

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 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: George M Ibrahim, MD, The Hospital for Sick Children

Phone: 416-813-7500

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
Not Applicable
Sponsor
The Hospital for Sick Children
Registry
ClinicalTrials.gov
Start date
11 September 2024
Est. completion
31 December 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Repetitive Behaviors Scale-Revised (RBS-R)

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: 23 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