Clinical trial NCT02414503 (phase 1/phase 2, status: completed)
Conditions: autism spectrum disorder
ICD codes: Z16.12
Drugs: 8iu intranasal oxytocin, 24iu intranasal oxytocin, placebo
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Eligibility 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.