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Taking people in BelgiumPhase 4

Oxytocin Treatment Tested in Children With Autism and Intellectual Disability

Tests repeated doses of oxytocin on social symptoms in children with autism and intellectual disability.

Key facts

Who runs it
UZ Leuven
Where
Leuven, BelgiumSee the site
Registry title
Evaluation of oxytocin treatment in children with autism and intellectual disability’, Multiple-dose Oxytocine - ASD and Intellectual Disability
Status
Recruiting
Phase
Phase 4
People taking part
80 people, planned
Started
30 May 2023
Planned end
1 Mar 2026
Type of study
Interventional
Record updated
4 April 2025

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Subjects who have had previous chronic treatment with oxytocin
  • 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
  • Significant hearing or vision impairments
  • Participation in another clinical trial with IMP

Where in Belgium

  • UZ LeuvenLeuven, BelgiumTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Evaluation of oxytocin treatment in children with autism and intellectual disability’, Multiple-dose Oxytocine - ASD and Intellectual Disability
Plain-language title
Oxytocin Treatment Tested in Children With Autism and Intellectual DisabilityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
4 April 2025