NCT02849743

Intranasal Oxytocin in Hypothalamic Obesity

Intranasal Oxytocin to Promote Weight Loss in Children, Adolescents, and Adults With Brain Tumors and Hypothalamic Obesity Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Shana McCormack, MD · Academic / Other
• Sex: All
• Age: 10 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This research study will test if oxytocin, delivered by nasal spray, will promote weight loss in children, adolescents, and adults with Hypothalamic Obesity as compared to a placebo. The study is divided into two parts. During the first part, subjects will receive either oxytocin or placebo. In the second part, subjects will "cross-over" to receive the other treatment - either oxytocin or placebo. During study visits participants will do blood tests, physical exams, metabolic testing, a MRI scan, and some surveys and questionnaires.

Conditions

• Craniopharyngioma
• Hypothalamic Obesity

Interventions

Type	Name	Description
DRUG	Syntocinon	The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
DRUG	Placebo (for Syntocinon)	The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-04-01
• Completion: 2022-05-01
• First posted: 2016-07-29
• Last updated: 2022-10-05
• Results posted: 2022-10-05

Locations

1 site across 1 country: United States