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Clinical Trials in Australia / NCT05590715
Recruiting Observational

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

NCT05590715 · tracked via the Priya Life Science Australia tracker
Sponsor
Stalicla SA
Phase
Observational
Started
2022-10-13
Last updated
2026-04-27

Condition(s) studied

Autism Spectrum Disorder

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations. — 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 — Day 0
    Better characterize subpopulations of ASD subjects and potentially identify/confirm a molecular signature specific of each subpopulation.

Trial sites (21)

FacilityCityRegionStatus
SARRC Phoenix Arizona Recruiting
California Neuroscience Research Sherman Oaks California Recruiting
BioPhase Research Miami Florida Terminated
The Angel Medical Research Miami Lakes Florida Withdrawn
Rush University Medical Center Chicago Illinois Recruiting
University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders Columbia Missouri Recruiting
Golden Hearts Diagnostic Alamogordo New Mexico Withdrawn
Red Oak Psychiatry Associates Houston Texas Withdrawn
Alpine Research Organization Clinton Utah Recruiting
Children's Health Queensland Hospital and Health Service South Brisbane Queensland Not Yet Recruiting
Mater Misericordiae Limited South Brisbane Queensland Not Yet Recruiting
Flinders Medical Centre Bedford Park South Australia Not Yet Recruiting
Locuspsych Melbourne Victoria Recruiting
Murdoch Children's Research Institute Parkville Victoria Not Yet Recruiting
Hospital General Universitario Dr Balmis Alicante Spain Recruiting
Hospital Clinic of Barcelona Barcelona Spain Recruiting
Hospital Infantil Universitario Nino Jesus (HIUNJS) Madrid Spain Recruiting
Hospital universitario Infanta Leonor Madrid Spain Recruiting
Hospital Universitario Puerta De Hierro Majadahonda Majadahonda Spain Terminated
Policlina Gipuzkoa San Sebastián Spain Active Not Recruiting
Hospital Álvaro Cunqueiro Vigo Spain Recruiting

Other trials for the same condition

ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD) Active, not recruiting
NTI164 in Autism Spectrum Disorder Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05590715 on ClinicalTrials.gov ↗ ← All trials in Australia