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NCT04219280 · ClinicalTrials.gov registry record · Phase 4
Evaluating Treatment of ADHD in Children with Down Syndrome
A Phase 4 study of ADHD and Down Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 4
- Study locations
NCT04219280: Recruiting Phase 4 study of ADHD and Down Syndrome, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04219280 is a Phase 4 study of ADHD and Down Syndrome that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 100 participants, below the 189-participant average among 75 other ADHD trials with a reported enrollment target (47% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04219280, a Phase 4 study of ADHD and Down Syndrome, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 4
- Study locations
Study Summary
Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though stimulants are the most efficacious ADHD treatment and are recommended by consensus guidelines for use in children with intellectual disability and ADHD. The investigators propose the first randomized clinical trial (RCT) of stimulant medication in children with DS+ADHD. This RCT may provide evidence regarding the short- and long-term safety and efficacy of stimulant use in children with DS+ADHD, both with and without CHD. All children enrolled in the study will complete a comprehensive assessment battery evaluating ADHD diagnostic criteria, as well as behavioral, cognitive, academic, and functional impairments.
Primary Outcome
A 49-item parent-report measure used to assess parent and teacher perceptions of youth's school and social functioning. The first 47 items assess symptoms of inattention, hyperactivity, combined inattention and hyperactivity, oppositional-defiant disorder, conduct disorder, and anxiety/depression. These items are scored on a 0-3 scale (0 = Never; 1 = Occasionally; 2 = Often; 3 = Very Often). The next two items measure impairment in performance and are scored on a 1-5 scale (1 = Above Average; 3
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Quillivant XR
Study Locations (4)
California
- University of California Davis MIND Institute - Sacramento
Massachusetts
- Boston Children's Hospital - Boston
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-10-02 |
| Est. Completion | 2025-09-30 |
| Phase | Phase 4 |
What NCT04219280 shows while recruiting
NCT04219280 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 189-participant average among 75 other ADHD trials with a reported enrollment target (47% lower).
The record links to 2 conditions, with ADHD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04219280 reports a single indexed study location in California, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT04219280 about?
NCT04219280 is a clinical study titled "Evaluating Treatment of ADHD in Children with Down Syndrome". Children with Down syndrome (DS) have a 3-5 time greater prevalence of Attention Deficit Hyperactivity Disorder (ADHD) than typically developing (TD) children. Despite this higher risk of ADHD, rates of stimulant medication treatment are disproportionately low in children with DS+ADHD, even though s...
What is the current status of trial NCT04219280?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2020-10-02. Estimated completion is 2025-09-30.
What conditions does trial NCT04219280 study?
This clinical trial studies the following conditions: ADHD, Down Syndrome.
What interventions are being tested in trial NCT04219280?
The interventions under investigation include: Placebo (DRUG), Quillivant XR (DRUG).
Who is sponsoring clinical trial NCT04219280?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04219280 being conducted?
This trial has 4 study locations across California, Massachusetts, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04219280's enrollment target sits among peer trials
100 34th of 75 higher than 41 of 75 other ADHD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other ADHD 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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