Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT02414503
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02414503
Study Brief:
Protocol Section:
NCT02414503