Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
AWARE: Management of ADHD in Autism Spectrum Disorder
NCT05916339 · View on ClinicalTrials.gov ↗
Study Summary
This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.
Conditions Studied
Interventions
- DRUG Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication
- DRUG Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.
Study Locations (12)
California
- University of California, Irvine — Irvine
- Children's Hospital Los Angeles — Los Angeles
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Nationwide Children's Hospital — Columbus
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
- University of Pittsburgh — Pittsburgh
Other
- University of Alberta, Glenrose Rehabilitation Hospital — Edmonton
- Holland Bloorview Kids Rehabilitation Hospital — Toronto
Maine
- Maine Medical Center — Portland
Massachusetts
- Massachusetts General Hospital Lurie Center for Autism — Boston
New York
- University of Rochester — Rochester
Virginia
- University of Virginia — Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05916339
The ClinicalTrials.gov registry entry for NCT05916339 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daniel Coury, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions — of which Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05916339 reports 12 study locations spanning 8 distinct geographic areas — top geographies include California, Ohio, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05916339 about?
NCT05916339 is a clinical study titled "AWARE: Management of ADHD in Autism Spectrum Disorder". This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will ...
What is the current status of trial NCT05916339?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 500 participants. The study started on 2023-10-01. Estimated completion is 2027-12-30.
What conditions does trial NCT05916339 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, ADHD. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05916339?
The interventions under investigation include: Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication (DRUG), Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant. (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05916339?
This trial is sponsored by Daniel Coury, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05916339 being conducted?
This trial has 12 study locations across California, Maine, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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