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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Intranasal Oxytocin for Infants With Prader-Willi Syndrome

NCTNCT03245762 (opens ClinicalTrials.gov in a new tab)Other idIRB201700423 -AOther idOCR16237
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
15 participants (actual)
Sponsor
University of Florida · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
1 Aug 2017
Primary completion
4 Jan 2018
Completion
4 Jan 2018
First posted
10 Aug 2017
Last update posted
26 Mar 2020
Conditions
Prader-Willi Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 1/2

    Intranasal Oxytocin for Infants With Prader-Willi Syndrome

    NCT03245762

    1 Aug 2017 to 4 Jan 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to compare the change in suck and swallow competency from baseline to morning of day 6 with intranasal oxytocin spray vs placebo in infants/children with Prader-Willi Syndrome who are in nutritional phase 1a. Videofluoroscopic swallow studies will be performed on treatment day 1 and on the day following treatment morning of day 6.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Intranasal oxytocin

    Intervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning.

  • Placebo comparator

    IN-placebo

    Intervention: 4 IU/day of placebo via nasal spray device each morning.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a

    Time frame · baseline to day 5

    Registry description

    Swallow study Overall improvement

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· baseline to day 5

Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a

GroupValue (Participants)
Intranasal Oxytocin8
IN-placebo4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Intranasal OxytocinIntervention: 4 IU/day of intranasal oxytocin via a nasal spray device each morning. Oxytocin: 4 IU/day of oxytocin administered via nasal spray device each morning.0 / 100 / 100 / 10
IN-placeboIntervention: 4 IU/day of placebo via nasal spray device each morning. Placebo: 4 IU/day of placebo administered via nasal spray device each morning0 / 50 / 50 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 1 Week up to 6 Months
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Individuals with genetically confirmed PWS who are in nutritional phase 1a, as determined by PI 2. Physical exam and laboratory results that are within the normal range. 3. Presence of a parent/caregiver/guardian that is able to consent for their participation. Exclusion Criteria: 1. Exposure to any investigational agent in the 30 days prior to randomization. 2. Prior chronic treatment with oxytocin. 3. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger the subject's well-being.

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