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Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome

NCT02804373 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-05

No results posted yet for this study

Summary

The investigator thinks that the oxytocin (OT) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome (SPW). Although today several studies demonstrated the effects of the OT in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients SPW.

Conditions

Interventions

DRUG

Oxytocin (OXT) continuous

Administration of 24 IU of oxytocin daily during 28 days

DRUG

Placebo

Placebo daily during 28 days

DRUG

Placebo continuous

Placebo administration the following 2 days after each OXT administration, during 28 days.

DRUG

Oxytocin

Administration of 24 IU of oxytocin every 3 days during 28 days.

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Maithé TAUBER, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2019-01-31
Completion
2019-06-18

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02804373 on ClinicalTrials.gov