CompletedPhase 2/3

Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome

France25 participantsStarted 2022-04-05

Plain-language summary

This phase 2B is designed to test the effectiveness of intranasal Oxytocin on Prader Willi Syndrome (PWS). This is a prospective, multicentre, randomised, double-blind, Phase 2B clinical study planned to include around 24 PWS patients aged 2-17 years and 5 months.

Who can participate

Age range2 Years – 17 Years

SexALL

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Inclusion criteria

✓. Male or female patients between 2 years and 17 years and 5 months at inclusion.
✓. Genetically confirmed diagnosis of PWS.
✓. Parents (or legal representative) have signed the informed consent form and are willing to comply with all study procedures.

Exclusion criteria

✕. A history of hypersensitivity to the study drug or drugs with similar chemical structures, to excipients of the product, or to latex;
✕. Intolerance of intranasal administrations (including when due to a major behavioural problem);
✕. Hyponatremia (clinically relevant at the discretion of the investigator);
✕. Hypokalaemia (clinically relevant at the discretion of the investigator);
✕. Prolongation of the QT interval and/or family history of prolongation of the QT interval;
✕. Concomitant treatment prolonging the QT interval;
✕. Start of growth hormone (GH) treatment within the last 4 weeks before inclusion;
✕. History of abnormal electrocardiogram (ECG) (validated by a cardiologist);

What they're measuring

videofluoroscopic swallowing study (VFSS) score change

Timeframe: after 12 weeks oxytocin (OT) / placebo (at V2)

Trial details

NCT IDNCT05298085

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-11

View on ClinicalTrials.gov More Prader-Willi Syndrome trials