The use of oxytocin for Autism Spectrum Disorder with Intellectual Disability

Phase 1

• Conditions: Autism Spectrum Disorder; MedDRA version: 21.1Level: PTClassification code 10067989Term: Intellectual disabilitySystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: PTClassification code 10063844Term: Autism spectrum disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]

• Registration Number: EUCTR2022-002423-36-BE
• Lead Sponsor: KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-20
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified