NCT05864508Not yet recruitingPhase 2
Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study.
Source: ClinicalTrials.gov · Last updated 18 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 9 May 2023
- Start date
- Jul 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Autism
- NCT number
- NCT05864508
- EudraCT number
- 2022-000254-28
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From Jul 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of an ECG considered to be clinically significant abnormal (validated by a cardiologist)
- Type 1 or 2 diabetes
- History of epilepsy or seizures
- Severe cardiovascular disease (tachycardia, bradycardia, arrhythmias, hypertension, hypotension, myocardial ischemia)
- Latex allergy
Lab values
- Criteria respecting the Syntocinon SPC:
- Hypersensitivity to Syntocinon
- Hyponatremia \< 135 mmol/L
- Hypokalaemia \< 3.5 mmol/L
- Hypertension or hypotension
- Hepatic impairment (ALT and/or AST \> 3N)
- Kidney failure (creatinine \> 3 N)
- Prolongation of the QT interval and/or family history of QT prolongation linked to an identified genetic etiology (QTc prolongation threshold \> 460 ms). \*\*
Age
- Sexually active women of childbearing age without effective contraception\*
Other
- The refusal of the holders of parental authority
- Pregnant girls, determined by a positive baseline blood pregnancy test
- Behavioral intolerance to the intranasal route
- Breastfeeding women
Who the study is looking for
- Minor benefiting from a social security scheme.
- Diagnosis:autism spectrum disorder according to the Diagnostic and Statistical Manual DSM -5 of severe intensity;
- Comorbidities:
- Moderate to severe intellectual disability
- Presence of challenging behavior objectified by means of clinical examination and the ABC and ABC-I scales
- Multi-professional psycho-educational and re-educational care : global and coordinated interventions associating, according to the needs, educational interventions by targeted objectives, therapeutic interventions involving functions that do not develop spontaneously, adaptation of the environment by structuring time and space, in close collaboration with the families.
- If prescribed psychotropic treatments (antipsychotics, anxiolytics, hypnotics/sedatives, antidepressants, psychostimulants and antiepileptics), the dosages must be stable for 3 months\*
- Understanding of French by both parents (if applicable) and ability for both parents to understand, in particular, the instructions for administering the product and to answer questionnaires.
- Informed consent signed by the holders of parental authority
Age in the registry: 6 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toulouse University Hospital Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.