Skip to content

Trial · Interventional

CompletedNot applicableRegistry data

Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.

Short name OT2SUITE

NCTNCT03081832 (opens ClinicalTrials.gov in a new tab)Other idRC31/16/8407Other id2016-A01348-43
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
34 participants (actual)
Sponsor
University Hospital, Toulouse · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

France

Start
Jan 2017
Primary completion
May 2018
Completion
Dec 2018
First posted
16 Mar 2017
Last update posted
30 Jan 2019
Conditions
Prader-Willi Syndrome

Timeline

1 trial · 1 completed

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

    OT2SUITE

    NCT03081832

    Jan 2017 to Dec 2018

Registry summary

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

The objective of this study is to collect data on tolerance and effects of early treatment with oxytocin in children with Prader Willi Syndrome aged from 3 to 4 years and to compare these infants with not treated age-matched infants with Prader Willi Syndrome.

Interventions

  • OxytocinDrug
  • ControlOther

Arms2

  • Experimental

    Oxytocin

    Groups of children with Prader Willi Syndrome treated by oxytocin for 7 days during their first 6 months of life.

  • Experimental

    Control

    Groups of children with Prader Willi Syndrome not treated by oxytocin for 7 days during their first 6 months of life.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Evaluation of communication skills.

    Time frame · Day 1

    Registry description

    Assessed by Vineland-II scale.

Secondary outcomes(6)

  1. Evaluation of adaptative behavior composite and 3 domains : "Daily living skills", "Socialization", "Motor skills".

    Time frame · Day 1

    Registry description

    Assessed by Vineland-II scale.

  2. Evaluation of behavioral troubles.

    Time frame · Day 1

    Registry description

    Assessed by Child Behaviour Check List questionnaire.

  3. Evaluation of global development.

    Time frame · Day 2 and 3

    Registry description

    Assessed by Bayley Scales of Infant and Toddler Development.

  4. Evaluation of orality and eating behaviour.

    Time frame · Day 2

    Registry description

    Assessed by: * A questionnaire on eating behavior. * An oral evaluation, which combines a clinical examination carried out by the reference center physician, and the assessment of eating behavior during the meal. * The fluoroscopy of swallowing.

  5. Evaluation of brain activity.

    Time frame · Day 3

    Registry description

    Assessed by a morphological Magnetic resonance imaging, a resting functional Magnetic resonance imaging.

  6. Evaluation of plasma levels of ghrelin and other peptides involved in feeding behaviour or energy metabolism.

    Time frame · Day 1

    Registry description

    Circulating levels of acylated and non-acylated ghrelin and some peptides and neuropeptides involved in appetite regulation (leptin, cortisol, insulin, Glucagon like peptide-1, pancreatic polypeptide, orexin A, alpha-melanocyte stimulating hormone...).

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

Studies12

Studies that cite this trial.

Studies with results

7 studies on this page

Indexing hint: Clinical trial · 2025

7 results

Early oxytocin treatment in infants with Prader-Willi syndrome is safe and is associated with better endocrine, metabolic and behavioral outcomes.

Valette et al. 2025Orphanet journal of rare diseasescited by 11

PMID 40025514PMC11872305DOI 10.1186/s13023-025-03560-3PUB-40025514

CC BY7 results
Download PDFSee results (7)

Indexing hint: Randomized controlled trial · 2012

5 results

Effects of intranasal oxytocin on social anxiety in males with fragile X syndrome.

Hall et al. 2012Psychoneuroendocrinologycited by 107

PMID 21862226PMC3353652DOI 10.1016/j.psyneuen.2011.07.020PUB-21862226

Rights unknown5 results
Source linkSee results (5)

Indexing hint: Randomized controlled trial · 2012

3 results

Oxytocin increases amygdala reactivity to threatening scenes in females.

Lischke et al. 2012Psychoneuroendocrinologycited by 156

PMID 22365820DOI 10.1016/j.psyneuen.2012.01.011PUB-22365820

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2010

2 results

Intranasal oxytocin improves emotion recognition for youth with autism spectrum disorders.

Guastella et al. 2010Biological psychiatrycited by 686

PMID 19897177DOI 10.1016/j.biopsych.2009.09.020PUB-19897177

Full text at the publisher2 results
Publisher pageSee results (2)

Indexing hint: Observational study · 2006

3 results

Oxytocin null mice ingest enhanced amounts of sweet solutions during light and dark cycles and during repeated shaker stress.

Billings et al. 2006Behavioural brain researchcited by 38

PMID 16677726DOI 10.1016/j.bbr.2006.03.028PUB-16677726

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Clinical trial · 2005

3 results

Oxytocin increases trust in humans.

Kosfeld et al. 2005Naturecited by 1,701

PMID 15931222DOI 10.1038/nature03701PUB-15931222

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Case report · 1995

3 results

Alterations in the hypothalamic paraventricular nucleus and its oxytocin neurons (putative satiety cells) in Prader-Willi syndrome: a study of five cases.

Swaab et al. 1995The Journal of clinical endocrinology and metabolismcited by 299

PMID 7852523DOI 10.1210/jcem.80.2.7852523PUB-07852523

Rights unknown3 results
Source linkSee results (3)

More studies

5 studies on this page

Indexing hint: Animal study · 2015

An Early Postnatal Oxytocin Treatment Prevents Social and Learning Deficits in Adult Mice Deficient for Magel2, a Gene Involved in Prader-Willi Syndrome and Autism.

Meziane et al. 2015Biological psychiatrycited by 174

PMID 25599930DOI 10.1016/j.biopsych.2014.11.010PUB-25599930

Full text at the publisher
Publisher page

Indexing hint: Animal study · 2010

A single postnatal injection of oxytocin rescues the lethal feeding behaviour in mouse newborns deficient for the imprinted Magel2 gene.

Schaller et al. 2010Human molecular geneticscited by 190

PMID 20876615DOI 10.1093/hmg/ddq424PUB-20876615

Full text at the publisher
Publisher page

Indexing hint: Review · 2008

Endogenous modulators of synaptic transmission: cannabinoid regulation in the supraoptic nucleus.

McDonald et al. 2008Progress in brain researchcited by 14

PMID 18655878PMC3569497DOI 10.1016/s0079-6123(08)00412-3PUB-18655878

Rights unknown
Source link

Indexing hint: Animal study · 2005

Enhanced initial and sustained intake of sucrose solution in mice with an oxytocin gene deletion.

Amico et al. 2005American journal of physiology. Regulatory, integrative and comparative physiologycited by 92

PMID 16150836DOI 10.1152/ajpregu.00558.2005PUB-16150836

Full text at the publisher
Publisher page

Indexing hint: Animal study · 1990

Oxytocin inhibits food and fluid intake in rats.

Arletti et al. 1990Physiology & behaviorcited by 198

PMID 2087513DOI 10.1016/0031-9384(90)90234-uPUB-02087513

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 3 Years up to 4 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Infants with Prader Willi Syndrome (genetic diagnosis confirmed) * For treated group : infant included in the ancient study * For not treated group: infant never treated with oxytocin Exclusion Criteria: * Subject involved in another search including an exclusion period still in progress at the time of inclusion. * Impossibility to give parents or legal guardian informed information * No coverage by a Social Security scheme * Refusal of parents or legal representative to sign consent. If a patient has a contraindication to Magnetic resonance imaging, it may be included in the study but Magnetic resonance imaging will not be performed.

PepBank is a research reference. Talk to a doctor before you use any peptide.