Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi … (NCT02629991) | Clinical Trial Compass
CompletedPhase 2
Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
United States23 participantsStarted 2015-10
Plain-language summary
The investigators propose a randomized double-blind 8 week treatment trial of intranasal oxytocin (IN-OXT) vs. placebo in 24 subjects aged 5 to 18 years with PWS in order to assess IN-OXT's affect on (1) Eating behaviors (2) Repetitive and disruptive behaviors and (3) Salivary OXT levels.
Who can participate
Age range5 Years – 18 Years
SexALL
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Inclusion criteria
✓. Male or Female child outpatients aged 5 to 18 years
✓. Diagnosis of PWS confirmed by genetic testing and patient medical records and history
✓. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to the study start, and for the duration of the study.
✓. Have a physical exam and laboratory results that are within the norms for PWS
✓. Have a parent/caregiver/guardian that is able to consent for their participation and complete assessments regarding the child's development and behavior improvement throughout the study.
Exclusion criteria
✕. Exposure to any investigational agent in the 30 days prior to randomization
✕. Prior chronic treatment with oxytocin.
✕. A primary psychiatric diagnosis other than ASD, including bipolar disorder, psychosis, schizophrenia, PTSD or major depressive disorder. These patients will be excluded due to potential confounding results.
✕. Pregnant or lactating patients. IN-OXT has not been studied in pregnant or lactating women.
✕. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger their own well-being.
✕. Plan to initiate or change nonpharmacologic or pharmacologic interventions during the course of the study.
What they're measuring
1
Hyperphagia Questionnaire (HQ)- Total Score
Timeframe: Assessed trends over multiple time points (weeks 0, 2, 4, 6, and 8), week 0 (baseline), week 4 and week 8 are reported.
✕. Females using an estrogen-based contraceptive. As an alternative to an estrogen based contraceptive, subjects will be counseled to use progesterone-based contraceptives; cervical caps; cervical sponges; or spermicidal foam in combination with a condom. Subjects will need to use a double barrier method to be in the study.