Evaluation of oxytocin treatment in children with autism and intellectual disability’, Multiple-dose Oxytocine - ASD and Intellectual Disability
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- 4. fázis
Where in Belgium
- UZ LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UZ Leuven
- Trial code
- EU 2024-513436-14-00
- Record updated
- 2025. április 4.
- Original description
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 stressRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: 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.