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NCT02013258 · ClinicalTrials.gov registry record · Phase 1
Oxytocin Trial in Prader-Willi Syndrome
A Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02013258: Completed Phase 1 study, sponsored by University of Florida.
NCT02013258 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02013258, a Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of this study is to determine if oxytocin (OT) administration will improve some of the aspects of Prader-Willi syndrome that are particularly troublesome for children and their families (the insatiable appetite and social behaviors). The research questions are: 1. Does intranasal oxytocin cause any side effects in children with PWS? 2. Does intranasal oxytocin administration alter appetite or behaviors in PWS?
Primary Outcome
Occurrence of adverse event, description and quantification of clinical and behavior severity, pre- and post- intranasal oxytocin and placebo administration.
Interventions
- OTHER Placebo
- DRUG Intranasal oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-03 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT02013258 record still lists
NCT02013258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02013258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02013258 about?
NCT02013258 is a clinical study titled "Oxytocin Trial in Prader-Willi Syndrome". Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of this study is to determine if oxytocin (OT) administration will improve some of the aspects of Prader-Willi syndrome that are ...
What is the current status of trial NCT02013258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-03. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02013258?
The interventions under investigation include: Placebo (OTHER), Intranasal oxytocin (DRUG).
Who is sponsoring clinical trial NCT02013258?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02013258's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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