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NCT00825591 · ClinicalTrials.gov registry record · Early Phase 1
Biological Clock Dysfunction in Optic Nerve Hypoplasia
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 100
- Enrollment target
NCT00825591: Completed Early Phase 1 study, sponsored by Yale University.
NCT00825591 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 100 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00825591, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
Background: Optic Nerve Hypoplasia (ONH) is a leading cause of blindness in children. For unclear reasons, the incidence of ONH is increasing, with ONH affecting about 1 in 10,000 live-born infants. In addition to visual deficits, ONH is associated with varying degrees of hypopituitarism, developmental delay, brain malformations and obesity. Although genetic mutations have been rarely observed to result in ONH, the causes of ONH are largely not known. In limited anatomical observations, the suprachiasmatic nuclei (SCN) located in the anterior hypothalamus, which generate circadian rhythms, have been observed to be abnormal in children with ONH. Thus, children with ONH may have biological clock dysfunction. In collaborative studies with Dr. Mark Borchert of Childrens Hospital Los Angeles (CHLA), we have recently discovered that one-half of children with ONH have grossly abnormal sleep-wake patterns, as assessed by actigraphy. Although not known for children with ONH, abnormal sleep-wake patterns have been observed to be associated with neurocognitive impairment and obesity. We also observe that nocturnal melatonin administration can improve abnormal sleep-wake cycles in these children, raising the possibility that it will be possible to treat abnormal rhythmicity in children with ONH.
Interventions
- DIETARY_SUPPLEMENT Melatonin
- DIETARY_SUPPLEMENT Placebo Comparator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-09 |
| Phase | Early Phase 1 |
What the finished NCT00825591 record still lists
NCT00825591 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, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% higher).
The record links to 0 conditions, and to 2 interventions - of which Melatonin is the first listed.
NCT00825591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00825591 about?
NCT00825591 is a clinical study titled "Biological Clock Dysfunction in Optic Nerve Hypoplasia". Background: Optic Nerve Hypoplasia (ONH) is a leading cause of blindness in children. For unclear reasons, the incidence of ONH is increasing, with ONH affecting about 1 in 10,000 live-born infants. In addition to visual deficits, ONH is associated with varying degrees of hypopituitarism, developmen...
What is the current status of trial NCT00825591?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2008-10. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00825591?
The interventions under investigation include: Melatonin (DIETARY_SUPPLEMENT), Placebo Comparator (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00825591?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00825591's enrollment target sits among peer trials
100 184th of 2000 higher than 1,783 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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