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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 October 2016
• Main ID: NCT02414503
• Date of registration: 31/03/2015
• Prospective Registration: Yes
• Primary sponsor: OptiNose AS
• Public title: Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder
• Scientific title: 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
• Date of first enrolment: April 2015
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02414503
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
• Phase: Phase 1/Phase 2

Countries of recruitment

Norway

Contacts

• Name: Ole A Andreassen, MD, PhD
• Affiliation: University of Oslo

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male subjects between the ages of 18 and 35, both inclusive, with a confirmed
diagnosis of autism spectrum disorder (ASD) diagnosis.

- Subjects must be in good general health, as determined by the investigator.

- Subject's pre-study physical examination, vital signs and electrocardiogram (ECG)
must not show any clinically significant abnormalities as determined by the
investigator.

- Subjects must be able to communicate well with the Investigator, to understand and
comply with the requirements of the study, and to understand the oral and written
patient information

- Provision of a signed, written informed consent.

Exclusion Criteria:

- Subjects showing major septal deviation or a significantly altered nasal epithelium.

- Subjects with evidence of previous nasal disease, surgery, and dependence on inhaled
drugs.

- Subjects with current significant nasal congestion due to common colds.

- Subjects with a clinically relevant history of significant hepatic, renal, endocrine,
cardiac, nervous, pulmonary, haematological or metabolic disorder.

- Psychiatric co-morbidity that requires intervention (e.g., psychosis spectrum
disorders, suicide intent)

- Systemic illness requiring treatment within 2 weeks prior to Study Day 1.

- History of significant drug or alcohol abuse (as per WHO Alcohol use disorder
identification test and drug use disorder identification test criteria) Subjects with
a positive screen for alcohol or drugs of abuse at screening/admission will be
excluded from participation in the study.

- Abnormal laboratory values which is deemed clinically significant by investigator.

- Full scale IQ < 75 (due to the prerequisite ability to complete self report
measures).

- Known allergic reactions or hypersensitivity to any component of the study medication
in the nasal spray, such as propyl parahydroxybenzoate (E216), methyl
parahydroxybenzoate (E218) and chlorobutanol hemihydrate.

- Participation in any (other) clinical trial with an investigational medicinal product
or medical device within 3 months prior to randomisation.

- Other unspecified reasons that, in the opinion of the investigator or the sponsor
make the subject unsuitable for enrollment.



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Autism Spectrum Disorder

Intervention(s)

Device: OptiNose Breath Powered Bi

Drug: 24IU intranasal oxytocin

Drug: 8IU intranasal oxytocin

Drug: Placebo

Primary Outcome(s)

Performance on a facial emotion morphing task [Time Frame: 45 mins after oxytocin/placebo administration]

Performance on an emotion sensitivity test [Time Frame: 45 mins after oxytocin/placebo administration]

Secondary Outcome(s)

Performance on the reading the mind in the eyes test [Time Frame: 45 mins after oxytocin/placebo administration]

Heart rate variability [Time Frame: 40 minutes after oxytocin/placebo administration]

Performance on an emotional dot probe task [Time Frame: 45 mins after oxytocin/placebo administration]

Eyetracking [Time Frame: 45 mins after oxytocin/placebo administration]

Secondary ID(s)

2014-005452-26

SMR-2728

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Oslo

Oslo University Hospital