autism MedDRA version: 20.0 Level: LLT Classification code 10003805 Term: Autism System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Syntocinon
Product Name: Syntocinon (Oxytocin)
Pharmaceutical Form: Nasal spray, solution
Pharmaceutical form of the placebo: Nasal spray, solution
Route of administration of the placebo:
Sponsors
University Hospital of Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Minor affiliated or beneficiary of a social security scheme. • Age: 6 – 12 years old (> 5 years old and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • The refusal of holders of parental authority • The absence of a recent general pediatric examination • The absence of a basic paraclinical assessment • The lack of balance of any other treatments taken by the child (stable dosages for at least 3 months (12 weeks) • Pregnant girls, determined by a positive baseline blood pregnancy test • Criteria respecting the Syntocinon SPC: - Hypersensitivity to Syntocinon - Hyponatremia - Hypokalemia hypertension or hypotension • Behavioral intolerance to the intranasal route • Hepatic impairment (ALAT>ASAT > 3N) • Kidney failure (creatinine > 3 N) • History of abnormal ECG (validated by a cardiologist) • Type 1 or 2 diabetes • Prolongation of the QT interval and/or family history of QT prolongation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess the feasibility of a protocol for administering OT intranasally as an adjuvant drug treatment to standard psycho-educational interventions in children aged 6 to 12 years with ASD of intensity severe and moderate to profound HI and presenting DC, at three levels: 1. The feasibility of setting up the pre-therapeutic and monitoring protocol for OT treatment: regular pediatric examination, taking blood samples, carrying out an electrocardiogram; 2. The feasibility of administering a daily OT intranasal spray treatment at the point of care and at home; 3. The safety profile of the medicinal product in this specific population at the two doses (4 IU then 8 IU).;Secondary Objective: The secondary objectives of the study include the evaluation of secondary feasibility criteria, the description of the population on certain genetic and hormonal parameters, the evaluation of the safety profile of the OT treatment as well as the description of the efficacy of the treatment. on a certain number of parameters, at the end of each of the administration periods.;Primary end point(s): The results will be considered positive if this percentage is greater than or equal to 80%, with a lower limit of the confidence interval of this estimate beyond 61.4%.;Timepoint(s) of evaluation of this end point: 14 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Precise statement of the reasons for a possible interruption of the protocol; - Qualitative assessment by caregivers and parents of the heaviness of implementing the protocol through semi-directive qualitative and quantitative interviews -ii. Constitution of a biological collection for the determination of ghrelin, acetylated ghrelin and circulating OT before and after treatment. These assays will be carried out later. - Results of the questionnaires;Timepoint(s) of evaluation of this end point: week 18 | — |
Countries
France
Contacts
Public ContactFlorine LEGAY
University Hospital of Toulouse
Outcome results
None listed