Back to results

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

Primary Purpose

Prader-Willi Syndrome

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Oxytocin (OXT) continuous

Placebo

Placebo continuous

Oxytocin

About this trial

This is an interventional treatment trial for Prader-Willi Syndrome focused on measuring oxytocin, adults

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre de référence Prader-Willi - Hôpital Purpan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo daily

24 IU of oxytocin daily

24 IU of oxytocin every 3 days

Arm Description

daily administration of placebo during 28 days : placebo continuous

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

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

Outcomes

Primary Outcome Measures

Change in Behaviour as assessed by score variations in specific questionaries

Change in eating Behaviour as assessed by score variations in specific questionaries

Secondary Outcome Measures

Change in eating behaviour as assessed by score variations in hunger visual analogic scale

Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)

Brain imaging

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

Brain imaging

Evaluation of social skills assessed by specific questionnaires

Evaluation of executive function assessed by specific questionnaires

Evaluation of theory of mind assessed by specific questionnaires

Social processing assessed by oculomotor exploration

Multisensory processing assessed by Neurovisual task

Hormon blood concentration levels as assessed by bioassays

Full Information

NCT ID

NCT02804373

First Posted

July 10, 2015

Last Updated

July 31, 2020

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT02804373

Brief Title

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

Acronym

PRADOTIM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

June 2014 (Actual)

Primary Completion Date

January 2019 (Actual)

Study Completion Date

June 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prader-Willi Syndrome

Keywords

oxytocin, adults

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

placebo daily

Arm Type

Placebo Comparator

Arm Description

daily administration of placebo during 28 days : placebo continuous

Arm Title

24 IU of oxytocin daily

Arm Type

Active Comparator

Arm Description

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

Arm Title

24 IU of oxytocin every 3 days

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Oxytocin (OXT) continuous

Other Intervention Name(s)

Syntocinon

Intervention Description

Administration of 24 IU of oxytocin daily during 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo daily during 28 days

Intervention Type

Drug

Intervention Name(s)

Placebo continuous

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Other Intervention Name(s)

Syntocinon

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Behaviour as assessed by score variations in specific questionaries

Time Frame

Every day before and after administration of treatment during 28 days

Title

Change in eating Behaviour as assessed by score variations in specific questionaries

Time Frame

Every day before and after administration of treatment during 28 days

Secondary Outcome Measure Information:

Title

Change in eating behaviour as assessed by score variations in hunger visual analogic scale

Time Frame

Every day before and after administration of treatment during 28 days

Title

Cerebral Metabolism variations as assessed by Positron Emission Tomography (PET-scan)

Description

Brain imaging

Time Frame

Day 1, day 2 and day 30

Title

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

Description

Brain imaging

Time Frame

Day 1, day 2 and day 29

Title

Evaluation of social skills assessed by specific questionnaires

Time Frame

Day 1, day 2 and day 30

Title

Evaluation of executive function assessed by specific questionnaires

Time Frame

Day 1, day 2 and day 30

Title

Evaluation of theory of mind assessed by specific questionnaires

Time Frame

Day 1, day 2 and day 30

Title

Social processing assessed by oculomotor exploration

Time Frame

Day 1, day 2 and day 30

Title

Multisensory processing assessed by Neurovisual task

Time Frame

Day 1, day 2 and day 30

Title

Hormon blood concentration levels as assessed by bioassays

Time Frame

Day 2 and day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maithé TAUBER, MD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre de référence Prader-Willi - Hôpital Purpan

City

Toulouse

ZIP/Postal Code

31059

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs