Autism spectrum disorder MedDRA version: 17.1 Level: PT Classification code 10063844 Term: Autism spectrum disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Syntocinon
Product Name: Oxytocin
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Oxytocin
CAS Number: 50-56-6
Other descriptive name: OXYTOCIN
Concentration unit: µg micro
Sponsors
OptiNose AS
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis. 2. Subjects must be in good general health, as determined by the investigator. ? 3. Subject’s pre-study physical examination, vital signs and electrocardiogram (ECG) must not show any clinically significant abnormalities as determined by the investigator. 4. 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.? 5. Provision of a signed, written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects showing major septal deviation or a significantly altered nasal epithelium. ? 2. Subjects with evidence of previous nasal disease, surgery, and dependence on inhaled drugs. ? 3. Subjects with current significant nasal congestion due to common colds. ? 4. Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder. ? 5. Psychiatric co-morbidity that requires intervention (e.g., psychosis spectrum disorders, suicide intent) 6. Systemic illness requiring treatment within 2 weeks prior to Study Day 1. 7. History of significant drug or alcohol abuse (as per WHO AUDIT/DUDIT criteria). Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study. ? 8. Abnormal laboratory values which is deemed clinically significant by investigator. ? 9. Full scale IQ < 75 (due to the prerequisite ability to complete self report measures). ? 10. 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. ? 11. Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation. 12. Other unspecified reasons that, in the opinion of the investigator or the sponsor make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to identify effects of 8 or 24 IU oxytocin delivered intranasally with the OptiNose N2B device on performance on social-cognitive tasks compared to placebo in adult patients diagnosed with autism spectrum disorder (ASD);Secondary Objective: • To identify effects of 8 or 24 IU oxytocin delivered intranasally with the OptiNose N2B device on physiological markers (heart rate variability, pupillometry, eye-tracking) compared to placebo • Assess differential effects of 8IU and 24IU on the primary cognitive and physiological endpoints • Determine and compare the plasma concentrations of oxytocin, vasopressin (AVP) and cortisol after 8 and 24 IU oxytocin delivered with OptiNose N2B devices in ASD patients • Document safety (adverse event profile) of intranasally administered oxytocin with Optinose N2B device in ASD patients ;Primary end point(s): The primary efficacy variables for this project are the social cognitive responses to the experimental task; o Performance on the theory of mind task o Performance on emotion sensitivity task o Eyegaze (fixation duration on eye region, time to first eye fixation) ;Timepoint(s) of evaluation of this end point: This will be evaluated after each dose administered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Physiological markers (heart rate variability, pupillometry) o Performance on dot probe task o Performance on facial morphing task o Plasma concentrations of oxytocin, vasopressin and cortisol ;Timepoint(s) of evaluation of this end point: This will be evaluated after each dose administered. | — |
Countries
Norway
Contacts
Public ContactClinical Trials Information
KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital
Outcome results
None listed