CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Intranasal Oxytocin (IN-OXT) +1 moredrug
Likely dose
Intranasal Oxytocin (IN-OXT) 16 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02629991
NCT02629991Phase 2Completed
CompareCT.gov

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

Montefiore Medical Center·interventional·Posted Dec 15, 2015·Updated Oct 7, 2021

In Brief

A Phase 2 clinical trial evaluating Intranasal Oxytocin (IN-OXT) and Matched Placebo for Prader-Willi Syndrome and Hyperphagia. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrader-Willi Syndrome, Hyperphagia
CountriesUnited States
CollaboratorsFoundation for Prader-Willi Research

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 15, 2015
Enrollment StartOct 1, 2015
Primary CompletionDec 1, 2016
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.5 years ago

Interventions

Intranasal Oxytocin (IN-OXT)drug

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

Matched Placeboother

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