Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome
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.
Timeline
- Start
- 2015-10
- Primary completion
- 2016-12
- Completion
- 2018-05
Outcome
Mixed primary results
registry analysis (superiority test); Intranasal Oxytocin vs Matched Placebo; p = 0.027 NCT02629991 ↗
registry MEAN Intranasal Oxytocin: Week 8: 10.36 (Standard Deviation 4.84) score on a scale NCT02629991 ↗
registry MEAN Matched Placebo: Week 8: 10.55 (Standard Deviation 4.48) score on a scale NCT02629991 ↗
registry analysis (superiority test); Intranasal Oxytocin vs Matched Placebo; p = 0.059 NCT02629991 ↗
registry analysis (superiority test); Intranasal Oxytocin vs Matched Placebo; p = 0.088 NCT02629991 ↗
registry analysis (superiority test); Intranasal Oxytocin (IN-OXT) vs Matched Placebo; p = 0.16 NCT02629991 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxytocin | Peptide | 16 iu | Intranasal |