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NCT02629991 · ClinicalTrials.gov registry record · Phase 2

Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome

A Phase 2 study of Prader-Willi Syndrome and Hyperphagia, sponsored by Montefiore Medical Center.

Completed
Registry status
Phase 2
Development phase
23
Enrollment target
1
Study location

NCT02629991 is a Phase 2 study of Prader-Willi Syndrome and Hyperphagia that has completed, run by Montefiore Medical Center. The registered enrollment target is 23 participants, below the 69-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02629991, a Phase 2 study of Prader-Willi Syndrome and Hyperphagia, has completed, sponsored by Montefiore Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
23 participants
Enrollment target
1
Study location

Study Summary

The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels.

Interventions

  • DRUG Intranasal Oxytocin (IN-OXT)
  • OTHER Matched Placebo

Study Locations (1)

New York

  • Montefiore Medical Center, Albert Einstein College of Medicine - The Bronx

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2015-10
Est. Completion 2018-05
Phase Phase 2

Sponsor

Montefiore Medical Center

345 total trials

What the Registry Record Tells You About NCT02629991

The ClinicalTrials.gov registry entry for NCT02629991 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 69-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (67% lower). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Prader-Willi Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Intranasal Oxytocin (IN-OXT) is the first listed.

NCT02629991 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT02629991 about?

NCT02629991 is a clinical study titled "Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome". The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels.

What is the current status of trial NCT02629991?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2015-10. Estimated completion is 2018-05.

What conditions does trial NCT02629991 study?

This clinical trial studies the following conditions: Prader-Willi Syndrome, Hyperphagia.

What interventions are being tested in trial NCT02629991?

The interventions under investigation include: Intranasal Oxytocin (IN-OXT) (DRUG), Matched Placebo (OTHER).

Who is sponsoring clinical trial NCT02629991?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02629991 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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