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Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome

NCT04283578 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-06-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

OT

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

DRUG

Placebo comparator

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

Sponsors & Collaborators

  • International Clinical Trials Association

    collaborator OTHER

  • Epidemiological and Clinical Research Information Network

    collaborator OTHER

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Maithé TAUBER, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
92 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2021-10-16
Completion
2022-03-14

Countries

  • Belgium
  • France
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283578 on ClinicalTrials.gov