Oxytocin Treatment in Neonates and Infants With Prader-Wi... | NCT04283578

Studies
Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome

NCT04283578

Sponsor

University Hospital, Toulouse

Status

Completed

Last Update Posted

Jun 1, 2023Actual

Enrollment

52Actual

Phase

Phase 3

Conditions

Prader-Willi Syndrome

Interventions

OT
Placebo comparator

Countries

Belgium
France
Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2020Actual

Primary Completion Date

Oct 16, 2021Actual

Completion Date

Mar 14, 2022Actual

First Submitted Date

Feb 19, 2020

First Submission Date that Met QC Criteria

Feb 21, 2020

First Posted Date

Feb 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2023

Last Update Posted Date

Jun 1, 2023Actual

Name	Class
International Clinical Trials Association	OTHER
Epidemiological and Clinical Research Information Network	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective, randomized, placebo-controlled, double-blind part of the phase III trial to assess the safety and efficacy of 4 weeks oxytocin (OT) administration on oral and social skills in neonates/infants with Prader-Willi Syndrome (PWS) aged less than 3 months at inclusion. Phase III clinical trial.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oxytocin	Experimental	intranasal administration of OT	Drug: OT Drug: Placebo comparator
Placebo	Placebo Comparator	intranasal administration of placebo	Drug: OT Drug: Placebo comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OT	Drug	One group will receive OT for 4 weeks, then placebo or OT for 8 weeks	Oxytocin Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neonatal Oral-Motor Assessment Scale (NOMAS) scale	the score goes from 8 to 28, the higher the score meaning a worse outcome	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Ghrelin dosage	Concentration of ghrelin (unacylated/UAG and acylated/AG)	Day 0, Week 1 and week 4
Oxytocin dosage	Plasma Oxytocin concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female neonate or infant, with PWS genetically confirmed.
Age <92 days (plus a tolerance of up to 8 days maximum) (for preterm infants, born before 37 weeks amenorrhea, corrected age will be applied).
Signed informed consent obtained from the parents/holders of parental authority.
Parents willing and able to comply with all study procedures.

Exclusion Criteria:

1. Neonate or infant currently admitted to the emergency care unit for ongoing life-threatening comorbidities like severe respiratory, cardiovascular or neurological abnormalities.

2. Neonate or infant with prolongation of the QT interval. 3. Neonate or infant without medical insurance. 4. Neonate or infant with hypersensitivity to oxytocin or excipients of the product.

5. Neonate or infant with concomitant treatment prolonging QT interval 6. Neonate or infant with family history of genetic pathology causing QT interval prolongation.

7. Neonate or infant with hypokalemia (clinically relevant at the discretion of the doctor).

8. Neonate or infant participating simultaneously in another interventional study.

9. Neonates or infants whose parents' situations may jeopardize the interpretation of the results.

10. Neonates or infants whose parents' refuse video recording, required to respond to the primary objective of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

92 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Maithé TAUBER, MD	University Hospital, Toulouse	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques Saint Luc		Brussels			Belgium
Hôpital Femme Mère Enfant

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33232306	Derived	Borie AM, Dromard Y, Guillon G, Olma A, Manning M, Muscatelli F, Desarmenien MG, Jeanneteau F. Correction of vasopressin deficit in the lateral septum ameliorates social deficits of mouse autism model. J Clin Invest. 2021 Jan 19;131(2):e144450. doi: 10.1172/JCI144450.

Type	Date	Date Unknown
Release	Jan 23, 2026
Reset	Feb 11, 2026

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 23, 2026			Feb 11, 2026
May 4, 2026

ID	Term
D008607	Intellectual Disability
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones