Phase 4 Autism Spectrum Disorder Trial, Recruiting NCT05916339 Sponsor: Daniel Coury Condition: Autism Spectrum Disorder
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Phase 4 Autism Spectrum Disorder Trial, Recruiting

NCT05916339
Recruiting Phase 4

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 and/or their legal caregiver must be willing and able to give consent for the child to take part in the study.
  • The child and/or their legal caregiver must be willing and able to follow all study requirements, in the opinion of the study investigator.
  • The child must be between 4 and 17 years old (inclusive) at the time of joining.
  • The child must have a confirmed diagnosis of Autism Spectrum Disorder (ASD), supported by records such as a referring doctor's report or formal assessment results.
  • The child must be able to take medication consistently, whether as a pill, liquid, or mixed with food or drink.
  • The child must have a confirmed diagnosis of ADHD, based on standard diagnostic criteria (DSM-5) and supporting evidence.
  • There must be a consistent person, such as a parent, who spends regular time with the child and can report on their behaviour.
  • Children already taking certain other psychiatric medications (such as SSRIs, atypical antipsychotics, or anticonvulsants) may be eligible, provided the dose has been stable for more than 4 weeks before joining and no dose changes are planned during the study.
  • It must have been at least 7 days since the child last took any ADHD medication, and the treating clinician must consider that to be a sufficient gap.
  • The caregiver must be sufficiently fluent in English or Spanish to complete the study questionnaires.

Who may not be able to join:

  • Children who have taken ADHD medication within the past 7 days.
  • Children who are not yet stable on other medications (i.e., have been on a current dose for fewer than 4 weeks).
  • Children who have any other health risk factor that the study team believes could make it unsafe for them to take the study medications (confirm with trial site).

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Daniel Coury, MD, Nationwide Children's Hospital

Phone: (614) 722-4006

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 4
Sponsor
Daniel Coury
Registry
ClinicalTrials.gov
Start date
1 October 2023
Est. completion
1 January 2027

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

The Vanderbilt Parent Rating Scale

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