CompletedPhase 2

Intranasal Oxytocin vs. Placebo for the Treatment of Hyperphagia in Prader-Willi Syndrome

United States32 participantsStarted 2018-04-11

Plain-language summary

This study is a phase 2 randomized double blind 8-week treatment trial of intranasal OXT vs. placebo in 50 subjects aged 5 to 17 years with PWS in order to assess IN-OXT's affect on measurements of (1) eating behaviors (2) repetitive behaviors (3) weight and body composition (4) quality of life (5) salivary OXT and hormone levels (including ghrelin, pancreatic polypeptide, peptide YY, Glucagon-Like Peptide-1 (GLP-1), insulin, glucagon, testosterone, and estrogen). If superior to placebo, this data will add to the current knowledge that OXT is an effective treatment for hyperphagia as well as other symptoms of PWS. Funding Source- FDA OOPD

Who can participate

Age range5 Years – 17 Years

SexALL

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Inclusion criteria

✓. Male or female pediatric outpatients aged 5 to 17 years
✓. Must be in PWS nutritional phase 2b or 3 as determined by PI
✓. Must be on growth hormone treatment and have been receiving stable doses of growth hormone treatment for at least 3 months prior to screening date. Treatment cannot have been interrupted for more than one week within 3 months of screening.
✓. Diagnosis of PWS confirmed by patient medical records.
✓. A score of at least moderate severity on the Hyperphagia Questionnaire for Clinical Trials at both screening and baseline visits.
✓. Stable dosages of hormone treatments (including testosterone and estrogen supplements) for 4 weeks prior to randomization and for the duration of the study.
✓. Stable dosages of metabolic treatments that could affect appetite (including metformin) for 4 weeks prior to randomization and for the duration of the study.
✓. Physical exam and laboratory results that are within the normal range for individuals with PWS.

Exclusion criteria

What they're measuring

Change in Efficacy of Peptide Intranasal Oxytocin (IN-OXT)

Timeframe: From Randomization at Baseline until Endpoint at Week 8 (Change over 8 weeks)

Trial details

NCT IDNCT03197662

SponsorEric Hollander

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-29

Results submitted2024-12-02

View on ClinicalTrials.gov More Prader-Willi Syndrome trials