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

NCT02804373 | Completed Phase 2

• 1 other identifier: 13 6872 03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Prader-Willi Syndrome

Keywords

oxytocin; adults

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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)

  Day 1, day 2 and day 30

• Cerebral Metabolism variations as assessed by functional Magnetic Resonance Imaging (f-RMI)

  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

Study Arms (3)

placebo daily

PLACEBO COMPARATOR

daily administration of placebo during 28 days : placebo continuous

Drug: Placebo continuous

24 IU of oxytocin daily

ACTIVE COMPARATOR

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

Drug: Oxytocin (OXT) continuous

24 IU of oxytocin every 3 days

ACTIVE COMPARATOR

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

Drug: Placebo; Drug: Oxytocin

Interventions

Oxytocin (OXT) continuous DRUG

Administration of 24 IU of oxytocin daily during 28 days

Also known as: Syntocinon

24 IU of oxytocin daily

Placebo DRUG

Placebo daily during 28 days

24 IU of oxytocin every 3 days

Oxytocin DRUG

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

Also known as: Syntocinon

24 IU of oxytocin every 3 days

Placebo continuous DRUG

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

placebo daily

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Centre de référence Prader-Willi - Hôpital Purpan

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 26994593 RESULT

MeSH Terms

Conditions

Prader-Willi Syndrome

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Maithé TAUBER, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: June 17, 2016
• Study Start: June 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: June 18, 2019
• Last Updated: December 5, 2025

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)