Effect of intranasal oxytocin on sosial cogitive tasks in autism spectrum disorder

Phase 1

• Conditions: Autism spectrum disorder; MedDRA version: 17.1Level: PTClassification code 10063844Term: Autism spectrum disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2014-005452-26-NO
• Lead Sponsor: OptiNose AS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-15
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 18

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified