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

NCT02629991 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-10-07

Study results available
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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.

Conditions

Interventions

DRUG

Intranasal Oxytocin (IN-OXT)

Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).

OTHER

Matched Placebo

Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).

Sponsors & Collaborators

  • Foundation for Prader-Willi Research

    collaborator OTHER

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Eric Hollander, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-12-31
Completion
2018-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02629991 on ClinicalTrials.gov