Oxytocin intranasal administrations in children with Prader-Willi syndrome aged from 3 to 12 years.

Effects of intranasal administrations of oxytocin on beahvioural troubles, hyperphagia and social skills in children with Prader-Willi syndrome aged from 3 to 12 years. - OXYJEUNE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003273-18-FR

Enrollment

Registered

2016-08-22

Start date

2016-11-14

Completion date

Unknown

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prader-Willi Syndrom

Interventions

Trade Name: Syntocinon Pharmaceutical Form: Nasal spray Pharmaceutical form of the placebo: Nasal spray Route of administration of the placebo: Nasal use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patient with a complete genetic diagnosis of PWS patient aged from 3 to 12 years patient treated by growth hormone for at least 1 year patient naïve for OXT for at least 5 years Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: patient who do not accept intranasal administrations (major behavioural trouble) patient with hepatic insufficiency : serum transaminases higher than 3 times normal values for age patient with renal insufficiency : serum creatinine higher than 3 times normal values for age patient with an antecedent of abnormal electrocardiogram patient with arterial hypertension or hypotension patient with type 1 or 2 diabetes

Design outcomes

Primary

Measure	Time frame
Main Objective: Study the effect of the administration intranasale of oxytocin (OXT) during 12 weeks on the behavior disorders by comparison with a placebo;Secondary Objective: Study the effect of the intranasal administration of OXT during 12 weeks by comparison with a placebo on : The hyperphagia The social skills The auto and hetero aggressives behaviors The psychopathology the global clinical state The evolution of the circulating rates of acyl and non acyl ghreline;Primary end point(s): evolution of behavioural troubles evaluated by the global score of CBCL questionnaire after 12 weeks of OXT or placebo treatment;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: Study the effect of the administration intranasale of oxytocin (OXT) during 12 weeks on the behavior disorders by comparison with a placebo;Secondary Objective: Study the effect of the intranasal administration of OXT during 12 weeks by comparison with a placebo on : The hyperphagia The social skills The auto and hetero aggressives behaviors The psychopathology the global clinical state The evolution of the circulating rates of acyl and non acyl ghreline;Primary end point(s): evolution of behavioural troubles evaluated by the global score of CBCL questionnaire after 12 weeks of OXT or placebo treatment;Timepoint(s) of evaluation of this end point: 12 weeks

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 12 weeks and at inclusion;Secondary end point(s): Evaluation of hyperphagia evaluated by Dykens questionnaire - social skills by PSA questionnaire for children aged from 3 to 6 years and by SRS questionnaire for children aged from 7 to 12 years. - auto- and hetero-aggressive behavior by ECAA questionnaire - psychopatholy of patient evaluated by the 3 following subscores of CBCL questionnaire - global clinical status of patient evaluated by a specific PWS grid - acyl and desacyl grelin plasma levels For patients aged from 7 to 12 years at inclusion: - attentional abilities by ANT (Attention Network Test) - metabolic brain resting state BY mri	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 12 weeks and at inclusion;Secondary end point(s): Evaluation of hyperphagia evaluated by Dykens questionnaire - social skills by PSA questionnaire for children aged from 3 to 6 years and by SRS questionnaire for children aged from 7 to 12 years. - auto- and hetero-aggressive behavior by ECAA questionnaire - psychopatholy of patient evaluated by the 3 following subscores of CBCL questionnaire - global clinical status of patient evaluated by a specific PWS grid - acyl and desacyl grelin plasma levels For patients aged from 7 to 12 years at inclusion: - attentional abilities by ANT (Attention Network Test) - metabolic brain resting state BY mri

—

Countries

France

Contacts

Public ContactALGANS

University Hospital of Toulouse

algans.n@chu-toulouse.fr+330561777204

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026