Oxytocin Trial in Prader-Willi Syndrome

Completed · Phase 1 · Has a placebo group

Conditions studied: Prader Willi Syndrome

In brief

Individuals with Prader-Willi syndrome (PWS) have been found to have a deficit of oxytocin-producing neurons and decreased oxytocin receptor gene function, so the purpose of this study is to determine if oxytocin (OT) administration will improve some of the aspects of Prader-Willi syndrome that are particularly troublesome for children and their families (the insatiable appetite and social behaviors). The research questions are: 1. Does intranasal oxytocin cause any side effects in children with PWS? 2. Does intranasal oxytocin administration alter appetite or behaviors in PWS?

Key facts

Study ID

NCT02013258

Run by

University of Florida

People needed

24

Starts

2015-03-01

Expected to finish

2015-08-01

Last updated by the study team

2018-04-05

Who can join

Age: 5 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children with genetically confirmed PWS
• Ages at ≥ 5 years and ≤ 11 years (must start treatment prior to 11th birthday)
• Child must be in nutritional phase 2b or 3, as determined by the PI at each site.
• Must currently be on growth hormone treatment, and have been receiving growth hormone treatment for at least one year prior to screening date.
• Treatment cannot have been interrupted for more than 1 week within 3 months prior to screening date.
• Priority will be given to children currently enrolled in the RDCRN Natural History study

You may not qualify if…

• Inability to tolerate intranasal administration of medication
• Hepatic insufficiency (AST/ALT greater than 3 times the normal levels for age)
• Renal insufficiency (BUN/Creatinine greater than 3 times the normal levels for age)
• History of an abnormal ECG (as determined by a cardiologist). If there is any question about cardiac function, ECG reports will be reviewed with a cardiologist prior to enrollment in the study.
• Child not receiving growth hormone treatment
• Child with hypertension or hypotension for age and sex (blood pressure >97% for age and sex or blood pressure <3% for age and sex)
• Diabetes mellitus
• Pregnant or lactating.
• Schizophrenia or psychosis
• Taking any psychotropic medications

Where it is running

• University of California, Irvine — Orange, California, United States
• University of Florida — Gainesville, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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