Autism Spectrum Disorder MedDRA version: 20.0 Level: LLT Classification code 10003805 Term: Autism System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Syntocinon
Product Name: Syntocinon
Product Code: N.A.
Pharmaceutical Form: Nasal spray, solution
Pharmaceutical form of the placebo: Nasal spray, solution
Route of administration of the p
Sponsors
AZIENDA OSPEDALIERA G. BROTZU
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Autism Spectrum Disorder. 2. Participants aged 18-45 years of age inclusive. 3. Gender: male. 4. IQ = 70 as measured with the WAIS-IV. 5. Signed consent. 6. Ability to complete tasks: adequate vision, motor control of a keyboard and mouse, and fluency in Italian. 7. Participant must be on a currently stable pharmacologic and/or psychoeducational treatments for at least 3 months and must not have made any treatment changes in the one month period prior to beginning this study. 8. Normality or not clinically significant abnormality identified on the medical or laboratory evaluation at the screening visit. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures. 9. Normality or not clinically significant abnormality vital Parameters (BP and HR included) at the screening visit. 10. Normal or not clinically significant 12-lead ECG reading at the screening visit. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Gender: female. 2. History of traumatic brain injury, epilepsy/seizure disorder (except febrile seizures), or other significant medical or genetic abnormality affecting brain function and motor, sensory or higher cognitive functioning. 3. Patients with one or more of the following: HIV, HBV, HCV, recent nose and brain injuries, immunity disorder. 4. Cardiac disorders (anamnesis, electrocardiogram, blood pressure and pulse): 50 = heart rate (bpm) = 90, 100 = blood pressure systolic (mmHg) = 140; 60 = blood pressure diastolic (mmHg) = 90. 5. Sensory impairments (e.g., significant vision/hearing loss). 6. Mental Retardation (e.g., IQ < 70, as measured with the WAIS-IV) or sensory-motor difficulties that would preclude valid use of diagnostic instruments. 7. Anamnestic known hypersensitivity to oxytocin or to any of the excipients of Syntocinon Nasal spray. 8. Anamnestic known hypersensitivity to nasal sprays or other drugs. 9. Fever or respiratory disease at the time of the baseline visit. 10. Judgment by the study physician or the PI that the patient is not suitable for the study due to unforeseeable safety issues. 11. Assumption of an investigational product within the following time period prior to the first dosing day in the current study: 6 months. 12. Unwillingness or inability to follow the procedures outlined in the protocol. 13. Use of inhalation anesthetics, e.g. cyclopropane or halotane within the following time period prior to the screening study day: one month. 14. Use of inhalation antibiotic(s) and inhalation anti-inflammatory drugs within the following time period prior to the screening study day: one month. 15. History of use of drugs of abuse and amphetamines. 16. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units . One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine. 17. Alcohol or nicotine (more than 15 cigarettes per day) abuse or dependence. 18. Intake of food, coffee, beverages (except water), nicotine-consumption within the 2 hours before the application of oxytocin/placebo.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety, the tolerability and the activity on social cognition of acute treatment of a single administration of IN-OXT versus placebo.;Secondary Objective: To evaluate the activity of acute treatment of a single administration of IN-OXT versus placebo on social cognition, repetitive behaviour and anxiety in ASD.;Primary end point(s): Safety and tolerability of IN-OXT in young adults with ASD.;Timepoint(s) of evaluation of this end point: About one month for each patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Differences between IN-OXT and placebo condition (between 0 and max 80 minutes since the IN-OXT / placebo administration ) on direct observation of repetitive behaviors.;Timepoint(s) of evaluation of this end point: About one month for each patient. | — |
Countries
Italy
Contacts
Public ContactUnit¿ di Ricerca Clinica
Azienda Ospedaliera G.Brotzu-Fase 1 srl
Outcome results
None listed