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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 is a Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 24 participants.

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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?

Interventions

  • OTHER Placebo
  • DRUG Intranasal oxytocin

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2015-03
Est. Completion 2015-08
Phase Phase 1

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT02013258

The ClinicalTrials.gov registry entry for NCT02013258 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02013258 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.