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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: Recruiting Phase 4 study of Autism Spectrum Disorder and ADHD, sponsored by Daniel Coury.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure is The Vanderbilt Parent Rating Scale for ADHD consists of 18 item, each scored from 0 to 3. It has a minimum score of 0, maximum score of 54. Higher scores indicate worse outcome.
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 |
What NCT05916339 shows while recruiting
NCT05916339 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (276% higher).
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 lists 12 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05916339's enrollment target sits among peer trials
500 11th of 224 higher than 211 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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