At a glance
ClinicalIndex Comparison Record- ✓Ages 10 to 35 years, inclusive.
- ✓Weight ≥51 kg.
- ✓Previously diagnosed with a brain tumor.
- ✓Currently overweight or obese (BMI >85th percentile for age/sex if <18 years; BMI >25 kg/m² if 18–35 years).
- ✕Diabetes insipidus without intact thirst mechanism and/or 'brittle' DI (>1 admission in past year or any admission in past 3 months).
- ✕Diabetes mellitus requiring insulin or insulin secretagogue; HbA1c ≥8%.
- ✕Abnormal blood pressure (<3rd percentile or >97th percentile for age, sex, height).
- ✕History of cardiac arrhythmia or arrhythmia on screening ECG.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intranasal Oxytocin to Promote Weight Loss in Children, Adolescents, and Adults With Brain Tumors and Hypothalamic Obesity Syndrome
In Brief
A Phase 2 clinical trial evaluating Syntocinon and Placebo (for Syntocinon) for Craniopharyngioma and Hypothalamic Obesity. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.