Oxytocin Treatment in Neonates and Infants 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

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2022-03-14

Brief Summary

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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.

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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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Oxytocin

intranasal administration of OT

Group Type EXPERIMENTAL

OT

Intervention Type DRUG

One group will receive OT for 4 weeks, then placebo or OT for 8 weeks

Placebo comparator

Intervention Type DRUG

One group will receive Placebo for 4 weeks, then Placebo or OT for 8 weeks.

Placebo

intranasal administration of placebo

Group Type PLACEBO_COMPARATOR

OT

Intervention Type DRUG

One group will receive OT for 4 weeks, then placebo or OT for 8 weeks

Placebo comparator

Intervention Type DRUG

One group will receive Placebo for 4 weeks, then Placebo or OT for 8 weeks.

Interventions

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OT

One group will receive OT for 4 weeks, then placebo or OT for 8 weeks

Intervention Type DRUG

Placebo comparator

One group will receive Placebo for 4 weeks, then Placebo or OT for 8 weeks.

Intervention Type DRUG

Other Intervention Names

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oxytocin

Eligibility Criteria

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Inclusion Criteria

1. Male or female neonate or infant, with PWS genetically confirmed.
2. 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).
3. Signed informed consent obtained from the parents/holders of parental authority.
4. 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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

92 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No