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NCT01033565 · ClinicalTrials.gov registry record · Phase 4
Melatonin CR for the Treatment of Impaired Sleep Maintenance in 4-8 Year Old Children With Autism Spectrum Disorders
A Phase 4 study, sponsored by University of Nebraska.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT01033565: Clinical Trial Phase 4 study, sponsored by University of Nebraska.
NCT01033565 is a Phase 4 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01033565, a Phase 4 study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems.
Primary Outcome
Assigns numerical score indicating level of improvement compared to baseline. Scale is rated from 1-7: 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; 7= very much worse.
Interventions
- DRUG Natrol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2010-03-04 |
| Est. Completion | 2010-10-01 |
| Phase | Phase 4 |
Why NCT01033565 stopped before completion
NCT01033565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Natrol is the first listed.
NCT01033565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01033565 about?
NCT01033565 is a clinical study titled "Melatonin CR for the Treatment of Impaired Sleep Maintenance in 4-8 Year Old Children With Autism Spectrum Disorders". The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems.
What is the current status of trial NCT01033565?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2010-03-04. Estimated completion is 2010-10-01.
What interventions are being tested in trial NCT01033565?
The interventions under investigation include: Natrol (DRUG).
Who is sponsoring clinical trial NCT01033565?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01033565's enrollment target sits among peer trials
1 2000th of 2000 the lowest 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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