Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Collaborator: Foundation for Prader-Willi Research
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

1. Male or Female child outpatients aged 5 to 18 years

2. Diagnosis of PWS confirmed by genetic testing and patient medical records and history

3. Stable pharmacologic, educational, behavioral and/or dietary interventions for 4 weeks prior to the study start, and for the duration of the study.

4. Have a physical exam and laboratory results that are within the norms for PWS

5. 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:

1. Exposure to any investigational agent in the 30 days prior to randomization

2. Prior chronic treatment with oxytocin.

3. 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.

4. Pregnant or lactating patients. IN-OXT has not been studied in pregnant or lactating women.

5. A medical condition that might interfere with the conduct of the study, confound interpretation of study results or endanger their own well-being.

6. Plan to initiate or change nonpharmacologic or pharmacologic interventions during the course of the study.

7. 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.