The use of oxytocin for Autism Spectrum Disorder with Intellectual Disability

Evaluation of oxytocin treatment in children with autism and intellectual disability - MOX-AID

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-002423-36-BE

Enrollment

Registered

2022-12-20

Start date

2023-05-30

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder MedDRA version: 21.1 Level: PT Classification code 10067989 Term: Intellectual disability System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: PT Classification code 10063844 Term: Autism spectrum disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Syntocinon (oxytocin), nasal spray 40IE/ml Product Name: Syntocinon (oxytocin) Product Code: 03716 Pharmaceutical Form: Nasal spray INN or Proposed INN: Oxytocin CAS Number: 50-56-6 Curren

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants eligible for inclusion have to meet all of the following criteria: 1. Children within an age-range of 4 to 13 years old with a clinical multidisciplinary diagnosis of ASD; only prepubertal girls will be included (girls with onset of menstruation during the course of the trial are allowed to continue the treatment). 2. 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. Are the trial subjects under 18? yes Number of subjects for this age range: 80 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Participants eligible for this Trial must not meet any of the following criteria: 1. Patient takes anti-epileptic medication or has an active medical problems (e.g., serious liver, renal, or cardiac pathology) which influences the metabolism of oxytocin. 2. Significant hearing or vision impairments. 3. Subjects who have had previous chronic treatment with oxytocin 4. Participation in another clinical trial with IMP. 5. Known hypersensitivity to active substance or ingredients of the nasal spray 6. Patient has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome) Although not a formal exclusion criterion, use of antibiotics within the last 3 months will be screened for, and if present, stool samples will not be collected from the participant.

Design outcomes

Primary

Measure	Time frame
Main Objective: Exploring the clinical effects and neurophysiological mechanisms of a four-week course of multiple-dose oxytocin treatment in children with Autism Spectrum Disorders with comorbid intellectual disability (age 4-13 years) A primary objective is to measure changes from baseline after oxytocin administration on: •Behavioral measurements of core autism symptoms •Cardio electrophysiological measurements of stress ;Secondary Objective: A secondary objective of the trial is to examine changes from baseline after oxytocin administration on: •Other behavioral outcomes (e.g. sleep quality, adaptive function) The clinical trial also includes exploratory outcome measures examining treatment-mechanistic aspects of the oxytocin treatment: •Oxytocin and cortisol hormonal levels •Other neurophysiological measurements of stress •Microbiome compositions ;Primary end point(s): The following clinical primary endpoints are specified: Assessment of changes from baseline after oxytocin administration on core autism symptoms using: - The Brief Observation of Social Communication Change (BOSCC) (clinician-rated). - The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated) Also, the following primary electrophysiological endpoint is specified: Assessment of changes from baseline after oxytocin treatment on electrocardiography (ECG) recordings for the assessment of heart rate variability (HRV) during rest and during social stimulation. ;Timepoint(s) of evaluation of this end point: The ATEC will be acquired from the parents (caregivers) at four time points: at baseline (T0), immediately after the four-week treatment (T1), and at the follow-up sessions four weeks (T2) and six months post-treatment (T3). The BOSCC will be taken by the clinicians at three time points: at baseline (T0), immediately after the four-week treatment (T1) and at the first follow-up session; four weeks after the treatment (T2). Teachers will fill in the ATEC at	—

Measure

Time frame

Main Objective: Exploring the clinical effects and neurophysiological mechanisms of a four-week course of multiple-dose oxytocin treatment in children with Autism Spectrum Disorders with comorbid intellectual disability (age 4-13 years) A primary objective is to measure changes from baseline after oxytocin administration on: •Behavioral measurements of core autism symptoms •Cardio electrophysiological measurements of stress ;Secondary Objective: A secondary objective of the trial is to examine changes from baseline after oxytocin administration on: •Other behavioral outcomes (e.g. sleep quality, adaptive function) The clinical trial also includes exploratory outcome measures examining treatment-mechanistic aspects of the oxytocin treatment: •Oxytocin and cortisol hormonal levels •Other neurophysiological measurements of stress •Microbiome compositions ;Primary end point(s): The following clinical primary endpoints are specified: Assessment of changes from baseline after oxytocin administration on core autism symptoms using: - The Brief Observation of Social Communication Change (BOSCC) (clinician-rated). - The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated) Also, the following primary electrophysiological endpoint is specified: Assessment of changes from baseline after oxytocin treatment on electrocardiography (ECG) recordings for the assessment of heart rate variability (HRV) during rest and during social stimulation. ;Timepoint(s) of evaluation of this end point: The ATEC will be acquired from the parents (caregivers) at four time points: at baseline (T0), immediately after the four-week treatment (T1), and at the follow-up sessions four weeks (T2) and six months post-treatment (T3). The BOSCC will be taken by the clinicians at three time points: at baseline (T0), immediately after the four-week treatment (T1) and at the first follow-up session; four weeks after the treatment (T2). Teachers will fill in the ATEC at

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Secondary

Measure	Time frame
Secondary end point(s): The following clinical secondary endpoints are specified: - The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated) - The Developmental Behaviour Checklist (DBC) (Flemish version: Vragenlijst over Ontwikkeling en Gedrag, VOG) (parent (caregiver)-rated) - The Perceived Stress Scale (PSS) (parent (caregiver)-rated) - The Child Sleep Hygiene Questionnaire (CSHQ) (parent (caregiver)-rated) - The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver)-rated) Additionally, the trial will also encompass several treatment-mechanistic exploratory outcomes as specified in section E.6.13.1. ;Timepoint(s) of evaluation of this end point: The DBC will be assessed from the parents at baseline (T0), and one time as outcome assessment, namely at T3, the 6-month follow-up session. The ABAS will be assessed at the intake. The PSS, CSHQ and RBS-R will be assessed from the parents at four time points: at baseline (T0), immediately after the four-week treatment (T1), and at the follow-up sessions four weeks (T2) and six months post-treatment (T3). Teachers will complete the RBS-R at three time points: at baseline (T0), immediately after the four-week treatment (T1) and at the four weeks follow up (T2).	—

Measure

Time frame

Secondary end point(s): The following clinical secondary endpoints are specified: - The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated) - The Developmental Behaviour Checklist (DBC) (Flemish version: Vragenlijst over Ontwikkeling en Gedrag, VOG) (parent (caregiver)-rated) - The Perceived Stress Scale (PSS) (parent (caregiver)-rated) - The Child Sleep Hygiene Questionnaire (CSHQ) (parent (caregiver)-rated) - The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver)-rated) Additionally, the trial will also encompass several treatment-mechanistic exploratory outcomes as specified in section E.6.13.1. ;Timepoint(s) of evaluation of this end point: The DBC will be assessed from the parents at baseline (T0), and one time as outcome assessment, namely at T3, the 6-month follow-up session. The ABAS will be assessed at the intake. The PSS, CSHQ and RBS-R will be assessed from the parents at four time points: at baseline (T0), immediately after the four-week treatment (T1), and at the follow-up sessions four weeks (T2) and six months post-treatment (T3). Teachers will complete the RBS-R at three time points: at baseline (T0), immediately after the four-week treatment (T1) and at the four weeks follow up (T2).

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Countries

Belgium

Contacts

Public ContactKaat Alaerts

KU Leuven

kaat.alaerts@kuleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026