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NCT05916339 · ClinicalTrials.gov registry record · Phase 4
AWARE: Management of ADHD in Autism Spectrum Disorder
A Phase 4 study of Autism Spectrum Disorder and ADHD, sponsored by Daniel Coury.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 500
- Enrollment target
- 12
- Study locations
NCT05916339 is a Phase 4 study of Autism Spectrum Disorder and ADHD that is actively recruiting participants, run by Daniel Coury. The registered enrollment target is 500 participants, above the 133-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (276% higher). The trial reports 12 study locations across 8 states.
The verdict
NCT05916339, a Phase 4 study of Autism Spectrum Disorder and ADHD, is actively recruiting participants, sponsored by Daniel Coury.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 500 participants
- Enrollment target
- 12
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 133-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (276% higher). The listed sponsor is Daniel Coury, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT05916339 reports 12 study locations spanning 8 distinct geographic areas - top geographies include California, Ohio, Pennsylvania.
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.
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).
Who is sponsoring clinical trial NCT05916339?
This trial is sponsored by Daniel Coury, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.