International Multicentric Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder

To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Health Queensland Hospital and Health Service, South Brisbane, Queensland, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants previously diagnosed with ASD (DSM-5)
Available well-documented health records within the first 2 years of life
Participants must have a parent or reliable caregiver who agrees to provide information about the participant
Participants willing and consenting or assenting to participate.

Exclusion criteria

Episode of fever (i.e. ≥100.5 °F or ≥ 38 °C) or clinically significant illness without fever (as judged by the investigator), within 10 days before any study assessment.
If the investigator assesses any unwillingness or any medical condition that may prevent the subject from completing this study.

Treatment and study plan

Primary outcomes

Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations.

Time frame: Day 0

A semi-structured medical questionnaire will be administered to collect clinical (sign and symptoms) and anthropomorphic features.
Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations

Time frame: Day 0

Better characterize subpopulations of ASD subjects and potentially identify/confirm a molecular signature specific of each subpopulation.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Stalicla SA

Industry

Registry information

Official study title

International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2027
First posted: Oct 21, 2022
Registry last updated: Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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