Clinical trial • Phase III • Psychiatry

Oxytocin for Autism spectrum disorder | Intellectual disability

Phase III trial of Oxytocin for Autism spectrum disorder | Intellectual disability.

Overview

sodium chloride nose drops 0.9% (placebo); dose/schedule not specified-controlled Phase III trial across 1 site in Belgium.

Comparator: sodium chloride nose drops 0.9% (placebo); dose/schedule not specified
Target Sample Size: 80

Recruits 80 paediatric patients.

Vulnerable Population: Children aged 4 to 13 years are identified as a vulnerable population (isVulnerablePopulationSelected=true). Subject information and informed consent forms (L1_ICF and other subject information materials) are provided in multiple versions/languages (EN, NL, FR) and separate qualitative/quantitative materials are listed, but the record does not explicitly state who provides consent or the assent process.

{"criterion_text":"-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)."}
{"criterion_text":"-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"}

{"criterion_text":"-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)"}
{"criterion_text":"-Patient has a known syndrome that interacts with the reproductive hormonal system (e.g. Prader-Willi or Angelman syndrome)"}
{"criterion_text":"-Significant hearing or vision impairments"}
{"criterion_text":"-Subjects who have had previous chronic treatment with oxytocin"}
{"criterion_text":"-Participation in another clinical trial with IMP"}
{"criterion_text":"-Known hypersensitivity to active substance or ingredients of the nasal spray"}

{"endpoint_text":"-The Brief Observation of Social Communication Change (BOSCC) (clinician-rated)","definition_or_measurement_approach":"Clinician-rated BOSCC score assessing change in social communication."}
{"endpoint_text":"-The Autism Treatment Evaluation Checklist (ATEC) (parent (caregiver) and teacher-rated)","definition_or_measurement_approach":"Parent/caregiver and teacher-rated ATEC assessing autism treatment outcomes."}
{"endpoint_text":"-Recordings of electrocardiography (ECG) for the assessment of heart rate variability (HRV) during rest","definition_or_measurement_approach":"ECG recordings to assess heart rate variability (HRV) at rest as a physiological measure of stress."}

{"endpoint_text":"-The Repetitive Behavior Scale - Revised (RBS-R) (parent (caregiver) and teacher-rated)","definition_or_measurement_approach":"Parent/caregiver and teacher-rated RBS-R to assess repetitive behaviours."}
{"endpoint_text":"-The Adaptive Behavior Assessment System (ABAS-3) (parent (caregiver)-rated)","definition_or_measurement_approach":"Parent-rated ABAS-3 assessing adaptive behaviour."}
{"endpoint_text":"-The Developmental Behaviour Checklist (DBC) (parent (caregiver)-rated)","definition_or_measurement_approach":"Parent-rated DBC assessing behavioural and emotional problems."}
{"endpoint_text":"-The Perceived Stress Scale (PSS) (parent (caregiver)-rated)","definition_or_measurement_approach":"Parent-rated PSS assessing perceived stress."}
{"endpoint_text":"-The Child’s Sleep Habits Questionnaire Abbreviated (CSHQ-A) (parent (caregiver)-rated)","definition_or_measurement_approach":"Parent-rated CSHQ-A assessing child sleep habits."}

{"endpoint_text":"-The clinical trial also includes exploratory outcome measures examining treatment-mechanistic aspects of the oxytocin treatment: 1. Oxytocin and cortisol hormonal levels 2. Other neurophysiological measurements of stress 3. Microbiome assessments","definition_or_measurement_approach":"Exploratory mechanistic measures including hormone assays (oxytocin, cortisol), additional neurophysiological stress measurements, and microbiome analyses."}

Digital Remote Recruitment: True, recruitment materials include website text and electronic brochures/flyers (Tekst website, PDFs of brochures and flyers) indicating use of online/digital channels.
Planned Sample Size: 80
Recruitment Window Months: 29
Consent Approach: Subject information and informed consent forms are available (L1_ICF and other subject information materials) in multiple languages (EN, NL, FR) with qualitative and quantitative versions; the record lists these documents but does not explicitly state who provides consent or details of assent procedures.

Use of recruitment brochures and flyers (files: Brochure_qualitative_EN, Brochure_quantitative_EN/FR/NL, Flyer_qualitative_EN/NL, Flyer_quantitative_EN/FR/NL).
Website text recruitment material (file: Tekst website) provided as part of recruitment materials.
Provision of subject information materials and informed consent forms in multiple languages (files: informatiebrief and ICF documents) for parents/caregivers of eligible children.

Investigational Product Name: Oxytocine CD Pharma 40 IE/ml neusspray, oplossing
Active Substance: Oxytocin
Modality: Peptide/protein/enzyme
Routes Of Administration: INTRANASAL USE
Route: Intranasal
Authorisation Status: Authorised (marketing authorisation RVG 03716 in NL)
Maximum Dose: Max daily 24 IU; max total 288 IU

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