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Trial · Interventional

CompletedPhase 1Registry data

Oxytocin Trial in Prader-Willi Syndrome

NCTNCT02013258 (opens ClinicalTrials.gov in a new tab)Other id5208-N
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Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
University of Florida · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Mar 2015
Primary completion
Aug 2015
Completion
Aug 2015
First posted
17 Dec 2013 (estimated)
Last update posted
5 Apr 2018
Conditions
Prader Willi Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016
  1. Ph 1

    Oxytocin Trial in Prader-Willi Syndrome

    NCT02013258

    Mar 2015 to Aug 2015

Registry summary

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

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

  • Intranasal oxytocinDrug
  • PlaceboOther

Arms2

  • Active comparator

    Intranasal oxytocin

    Intranasal oxytocin. 16 IU intranasal oxytocin x 5 days. One month interval between arms of treatment.

  • Placebo comparator

    Placebo

    Placebo will be administered via nasal spray - 1 spray in each nostril x5 days.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Safety of intranasal oxytocin in children with Prader-Willi syndrome

    Time frame · 3 months

    Registry description

    Occurrence of adverse event, description and quantification of clinical and behavior severity, pre- and post- intranasal oxytocin and placebo administration.

Secondary outcomes(1)

  1. Evaluation of food intake in Prader-Willi syndrome

    Time frame · 3 months

    Registry description

    Quantitative evaluation of hyperphagia via the Hyperphagia Questionnaire obtained on days 1, 4 and 6 during the 7 day study protocol and conducted in the evening on these days. Score will range from 0 (no hyperphagia behaviors) to 96 (most severe hyperphagia behaviors). Additionally quantity of food consumed will be recorded on Days 1,4, and 6.

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2011

5 results

Oxytocin may be useful to increase trust in others and decrease disruptive behaviours in patients with Prader-Willi syndrome: a randomised placebo-controlled trial in 24 patients.

Tauber et al. 2011Orphanet journal of rare diseasescited by 81

PMID 21702900PMC3141367DOI 10.1186/1750-1172-6-47PUB-21702900

CC BY5 results
Download PDFSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 5 Years up to 11 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Children with genetically confirmed PWS * Ages at ≥ 5 years and ≤ 11 years (must start treatment prior to 11th birthday) * Child must be in nutritional phase 2b or 3, as determined by the PI at each site. * Must currently be on growth hormone treatment, and have been receiving growth hormone treatment for at least one year prior to screening date. * Treatment cannot have been interrupted for more than 1 week within 3 months prior to screening date. * Priority will be given to children currently enrolled in the RDCRN Natural History study Exclusion Criteria: * Inability to tolerate intranasal administration of medication * Hepatic insufficiency (AST/ALT greater than 3 times the normal levels for age) * Renal insufficiency (BUN/Creatinine greater than 3 times the normal levels for age) * History of an abnormal ECG (as determined by a cardiologist). If there is any question about cardiac function, ECG reports will be reviewed with a cardiologist prior to enrollment in the study. * Child not receiving growth hormone treatment * Child with hypertension or hypotension for age and sex (blood pressure \>97% for age and sex or blood pressure \<3% for age and sex) * Diabetes mellitus * Pregnant or lactating. * Schizophrenia or psychosis * Taking any psychotropic medications

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