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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-06-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Prader-Willi Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo daily

daily administration of placebo during 28 days : placebo continuous

Group Type PLACEBO_COMPARATOR

Placebo continuous

Intervention Type DRUG

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

24 IU of oxytocin daily

24 IU of daily oxytocin administration during 28 days : oxytocin continuous

Group Type ACTIVE_COMPARATOR

Oxytocin (OXT) continuous

Intervention Type DRUG

Administration of 24 IU of oxytocin daily during 28 days

24 IU of oxytocin every 3 days

24 IU of daily oxytocin every 3 days and placebo the following 2 days after each oxytocin administration during 28 days

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo daily during 28 days

Oxytocin

Intervention Type DRUG

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

Interventions

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Oxytocin (OXT) continuous

Administration of 24 IU of oxytocin daily during 28 days

Intervention Type DRUG

Placebo

Placebo daily during 28 days

Intervention Type DRUG

Placebo continuous

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

Intervention Type DRUG

Oxytocin

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

Intervention Type DRUG

Other Intervention Names

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Syntocinon Syntocinon

Eligibility Criteria

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Inclusion Criteria

* Prader-Willi syndrome genetically confirmed
* Absence of extension of the QT interval in the electrocardiogram
* Absence of hypokalemia

Exclusion Criteria

* Psychiatric troubles
* Anomalies of the heart rhythm in significant ECG
* Hepatic insufficiency
* Renal insufficiency
* Patients presenting a pregnancy or breast-feeding
* High sensibility to OT
* High sensibility to the excipients of the product
* Patients having family history of genetic pathology causing an extension of the interval QT
* Patients having risk factors of advanced twist

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No