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

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.

Study Overview

• Status: Completed
• Conditions: Prader-Willi Syndrome
• Intervention / Treatment: Drug: Placebo continuous; Drug: Oxytocin (OXT) continuous; Drug: Placebo; Drug: Oxytocin

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Centre de référence Prader-Willi - Hôpital Purpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo daily; daily administration of placebo during 28 days : placebo continuous	Drug: Placebo continuous; Placebo administration the following 2 days after each OXT administration, during 28 days.
Active Comparator: 24 IU of oxytocin daily; 24 IU of daily oxytocin administration during 28 days : oxytocin continuous	Drug: Oxytocin (OXT) continuous; Administration of 24 IU of oxytocin daily during 28 days; Other Names: Syntocinon
Active Comparator: 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	Drug: Placebo; Placebo daily during 28 days; Drug: Oxytocin; Administration of 24 IU of oxytocin every 3 days during 28 days.; Other Names: Syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Behaviour as assessed by score variations in specific questionaries	Every day before and after administration of treatment during 28 days
Change in eating Behaviour as assessed by score variations in specific questionaries	Every day before and after administration of treatment during 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in eating behaviour as assessed by score variations in hunger visual analogic scale		Every day before and after administration of treatment during 28 days
Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)	Brain imaging	Day 1, day 2 and day 30
Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI)	Brain imaging	Day 1, day 2 and day 29
Evaluation of social skills assessed by specific questionnaires		Day 1, day 2 and day 30
Evaluation of executive function assessed by specific questionnaires		Day 1, day 2 and day 30
Evaluation of theory of mind assessed by specific questionnaires		Day 1, day 2 and day 30
Social processing assessed by oculomotor exploration		Day 1, day 2 and day 30
Multisensory processing assessed by Neurovisual task		Day 1, day 2 and day 30
Hormon blood concentration levels as assessed by bioassays		Day 2 and day 30

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Maithe TAUBER, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• Salles J, Strelnikov K, Carine M, Denise T, Laurier V, Molinas C, Tauber M, Barone P. Deficits in voice and multisensory processing in patients with Prader-Willi syndrome. Neuropsychologia. 2016 May;85:137-47. doi: 10.1016/j.neuropsychologia.2016.03.015. Epub 2016 Mar 16.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): June 18, 2019

Study Registration Dates

• First Submitted: July 10, 2015
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimated): June 17, 2016

Study Record Updates

• Last Update Posted (Estimated): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: oxytocin; adults
• Additional Relevant MeSH Terms: Imprinting Disorders; Neurologic Manifestations; Nervous System Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Overnutrition; Neurobehavioral Manifestations; Congenital Abnormalities; Abnormalities, Multiple; Overweight; Intellectual Disability; Obesity; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Prader-Willi Syndrome; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pituitary Hormones, Posterior; Pituitary Hormones; Oxytocin
• Other Study ID Numbers: 13 6872 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO