2024-513436-14-00RecruitingPhase 4
Evaluation of oxytocin treatment in children with autism and intellectual disability’, Multiple-dose Oxytocine - ASD and Intellectual Disability
Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy of multiple-dose oxytocin treatment on core autism symptoms using standardized assessments in children with ASD and comorbid ID. Change from baseline after oxytocin administration on: -Behavioral measurements of core autism (social) symptoms -Cardio electrophysiological measurements of stress
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 12 Sept 2024
- Start date
- 30 May 2023
- Lead sponsor
- UZ Leuven
- Diseases
- Autism
- EU CT number
- 2024-513436-14-00
- EudraCT number
- 2022-002423-36
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 4 to 13 with autism and an intellectual disability. It tests oxytocin treatment on core autism symptoms.
- Age
- 4 to 13 years old
- Sex
- Boys and girls can join. Girls can join only before their periods have started.
- Disease stage
- A clinical diagnosis of autism spectrum disorder (ASD) made by a team of different specialists, and an intellectual disability: total IQ below 75 and ABAS score below 70, or attending a special needs school class for children with intellectual disability.
- Earlier treatment
- Children who have had long-term oxytocin treatment before cannot join.
Main reasons for not taking part
- Taking anti-epileptic medicine, or an active medical problem such as heart disease or serious liver or kidney problems that affects how oxytocin is handled
- A known syndrome that affects the reproductive hormone system, such as Prader-Willi or Angelman syndrome
- Significant hearing or vision problems
- Taking part in another clinical trial with a trial medicine
- Known allergy to the active substance or the other ingredients of the nasal spray
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who have had previous chronic treatment with oxytocin
Other illness
- Patient activelytakes anti-epileptic medication or has an active medical problem like cardiac pathology or serious liver, renal problems which influence the metabolism of oxytocin (IMP)
- Patient has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome)
- Known hypersensitivity to active substance or ingredients of the nasal spray
Other
- Significant hearing or vision impairments
- Participation in another clinical trial with IMP
Who the study is looking for
- Children within an age-range of 4 to 13 years old with a clinical multidisciplinary diagnosis of ASD; only premenstrual girls will be included (girls with onset of menstruation during the course of the trial are allowed to continue the treatment).
- Children must be enrolled in a special need school, more specific a class comprising children with an intellectual disability or meet intellectual disability criteria; a total IQ below 75 and an ABAS score below 70
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.