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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 is a Phase 4 study that was terminated before completion, run by Milton S. Hershey Medical Center. The registered enrollment target is 3 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02638168
The ClinicalTrials.gov registry entry for NCT02638168 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02638168 reports 0 study locations.
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.
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