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NCT02638168 · ClinicalTrials.gov registry record · Phase 4
Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD
A Phase 4 study, sponsored by Milton S. Hershey Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT02638168: Clinical Trial Phase 4 study, sponsored by Milton S. Hershey Medical Center.
NCT02638168 is a Phase 4 study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02638168, a Phase 4 study, was terminated before completion, sponsored by Milton S. Hershey Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these children have moderate to severe impairments in sleep, further exacerbating their already impaired academic, emotional and social functioning. In children with ADHD, 34% of prescribed sleep medications are antipsychotics that can cause marked weight gain and metabolic changes; alternate medications have either been found to be ineffective, difficult to tolerate or are largely unstudied in youth. Delayed sleep onset is strongly correlated with active symptoms of ADHD and Oppositional Defiant Disorder (ODD), suggesting that better control of disruptive behaviors could improve sleep patterns and this application will assess if the extension of the therapeutic effects of CNS stimulants into the early evening improves sleep onset.
Primary Outcome
Sleep onset latency is defines as duration of time in bed until sleep, as reported on the parent completed sleep log
Interventions
- DRUG Placebo
- DRUG Immediate Release Methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-01 |
| Est. Completion | 2018-06 |
| Phase | Phase 4 |
Why NCT02638168 stopped before completion
NCT02638168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02638168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02638168 about?
NCT02638168 is a clinical study titled "Effects of Evening Dose of Immediate Release Methylphenidate on Sleep in Children With ADHD". Over 10% of children in the United States are diagnosed with ADHD, and nearly half of these children have moderate to severe impairments in sleep, further exacerbating their already impaired academic, emotional and social functioning. In children with ADHD, 34% of prescribed sleep medications are an...
What is the current status of trial NCT02638168?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2016-01. Estimated completion is 2018-06.
What interventions are being tested in trial NCT02638168?
The interventions under investigation include: Placebo (DRUG), Immediate Release Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT02638168?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02638168's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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