OXYTOCIN SYNTHETIC for Autism spectrum disorder

Inclusion criteria

• {"criterion_text":"- Male and female participant between the ages of 12 and 20, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) using the Autism Diagnostic Observation Schedule (ADOS)."}
• {"criterion_text":"- Participants must be in good general physical health, as determined by the investigator."}
• {"criterion_text":"- Participants 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."}
• {"criterion_text":"- Provision of a signed, written informed consent, if 16 years and older. Participants between the ages of 12 and 15 (inclusive) will provide assent, with caregivers providing consent. Caregivers will also provide consent for research participation."}

Exclusion criteria

• {"criterion_text":"- Previous nasal disease, surgery, and dependence on inhaled drugs."}
• {"criterion_text":"- Current significant nasal congestion due to common colds."}
• {"criterion_text":"- Clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, pulmonary, haematological or metabolic disorder."}
• {"criterion_text":"- Systemic illness requiring treatment within 2 weeks prior to Study Day 1."}
• {"criterion_text":"- Full scale IQ < 70 (due to the prerequisite ability to complete self-report measures)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Known allergic reactions or hypersensitivity/intolerance to latex."}
• {"criterion_text":"- Currently breastfeeding."}
• {"criterion_text":"- Pregnancy (self-reported or assessed by pregnancy test prior to the first administration at Experimental session 1 and 3 for all menstruating females)."}
• {"criterion_text":"- Participation in any (other) clinical trial with an investigational medicinal product or medical device within 3 months prior to randomisation."}
• {"criterion_text":"- New concomitant medications or formal cognitive/behavioral therapies. If a participant has been taking any medications or receiving formal cognitive/behavioral therapies for at least 4 weeks, then this is not considered a new therapy."}
• {"criterion_text":"- Other unspecified reasons that, in the opinion of the investigator or the sponsor make the participants unsuitable for enrollment."}

Primary endpoints

• {"endpoint_text":"- The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on social behavior. This will be operationalized as change from baseline on performance on the Social Responsiveness Scale-Second Edition (SRS-2), completed by caregivers of the participants.","definition_or_measurement_approach":"Change from baseline on Social Responsiveness Scale-Second Edition (SRS-2) completed by caregivers."}
• {"endpoint_text":"- The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on repetitive behavior. This will be operationalized as change from baseline on performance on the Repetitive Behavior Scale-Revised (RBS-R) scale, completed by caregivers of the participants.","definition_or_measurement_approach":"Change from baseline on Repetitive Behavior Scale-Revised (RBS-R) completed by caregivers."}

Secondary endpoints

• {"endpoint_text":"- The effect of 24 IU oxytocin delivered intranasally, twice-daily, for four weeks, on behavioral inflexibility. This will be operationalized as change from baseline on performance on the Behavioral Inflexibility scale (BIS), completed by caregivers of the research participants","definition_or_measurement_approach":"Change from baseline on Behavioral Inflexibility scale (BIS) completed by caregivers."}

Norway

Earliest CTIS Part Ii Submission Date

29-05-2024

Latest Decision Or Authorization Date

09-10-2024

Processing Time Days

133

Number Of Sites

1

Number Of Participants

128

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway