NCT02414503

Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder

A Randomized, Placebo Controlled, Double-blind, 3-period Cross-over Study in Adult Patients With Autism Spectrum Disorders Evaluating Cognitive Response After Single- Dose Oxytocin 8 or 24 IU Intranasal Administration Using the OptiNose Bi-directional Nose-to-brain Device

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: OptiNose AS · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Oxytocin (OT) is a small, naturally occurring peptide currently in clinical use to stimulate lactation in breastfeeding women. The intranasal administration of OT has recently attracted attention as a potential novel treatment in several psychiatric disorders in autism. However, given the anatomy of the nasal cavity, the current design of nasal sprays would be expected to provide an inadequate delivery of medication to the areas of the nasal cavity where direct transport into the brain via the olfactory nerve could potentially occur. OptiNose has developed an intranasal delivery device that provides improved reproducibility of nasal delivery, improved deposition to the upper posterior regions of the nasal cavity where the olfactory nerve innervates the nasal cavity. The primary objective of this study is to identify any differences between a single dose of 8 international units (IU) oxytocin, 24 IU oxytocin, and placebo delivered intranasally with the optimised OptiNose device in volunteers with Autism Spectrum Disorder. This will be measured in terms of performance on cognitive tests and physiological markers.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	8IU intranasal oxytocin
DRUG	24IU intranasal oxytocin
DRUG	Placebo
DEVICE	OptiNose Breath Powered Bi

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-04-10
• Last updated: 2016-09-27

Locations

1 site across 1 country: Norway