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

NCT05590715 · tracked via the Priya Life Science Spain 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

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)

Facility	City	Region	Status
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The Angel Medical Research	Miami Lakes	Florida	Withdrawn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Golden Hearts Diagnostic	Alamogordo	New Mexico	Withdrawn
Red Oak Psychiatry Associates	Houston	Texas	Withdrawn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

Evaluation of the Effect of a Psychological Program for Children With Autism Spectrum Disorder and Feeding Difficulties Recruiting

Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents Active, not recruiting

Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years Recruiting

Aut-CARE Intervention to Improve Cognitive and Emotional Functioning in Young Adults on the Autism Spectrum Recruiting

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 Spain