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

April 24, 2026 updated by: Stalicla SA

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Not yet recruiting
        • Mater Misericordiae Limited
        • Contact:
          • Caitlin Bennett
      • South Brisbane, Queensland, Australia, 4101
        • Not yet recruiting
        • Children's Health Queensland Hospital and Health Service
        • Contact:
          • Emily Milburn
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Not yet recruiting
        • Flinders Medical Centre
        • Contact:
          • Rupali Saikia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
      • Parkville, Victoria, Australia, 3052
        • Not yet recruiting
        • Murdoch Children's Research Institute
        • Contact:
          • Kylie Crompton
  • Spain
      • Alicante, Spain, 30010
        • Recruiting
        • Hospital General Universitario Dr Balmis
        • Contact:
          • Maria Auxiliadora Javaloyes Sanchis, MD
        • Principal Investigator:
          • Maria Auxiliadora Javaloyes Sanchis, MD
      • Barcelona, Spain, 8036
        • Recruiting
        • Hospital Clinic of Barcelona
        • Contact:
          • Rosa Calvo Escalona, MD/PhD
        • Principal Investigator:
          • Rosa Calvo Escalona, MD/PhD
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
          • Francisco Javier Quintero Gutiérrez del Álamo, MD/PhD
        • Principal Investigator:
          • Francisco Javier Quintero Gutiérrez del Álamo, MD/PhD
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Nino Jesus (HIUNJS)
        • Contact:
          • Silvia Gutierrez Priego, MD
        • Principal Investigator:
          • Silvia Gutierrez Priego, MD
      • Majadahonda, Spain, 28222
        • Terminated
        • Hospital Universitario Puerta de Hierro Majadahonda
      • San Sebastián, Spain, 20014
        • Active, not recruiting
        • Policlina Gipuzkoa
      • Vigo, Spain, 36213
        • Recruiting
        • Hospital Alvaro Cunqueiro
        • Contact:
          • Jose Manuel Olivares Diez, MD/PhD
        • Principal Investigator:
          • Jose Manuel Olivares Diez, MD/PhD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • California
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • California Neuroscience Research
        • Contact:
    • Florida
      • Miami, Florida, United States, 33137
        • Terminated
        • BioPhase Research
      • Miami Lakes, Florida, United States, 33016
        • Withdrawn
        • The Angel Medical Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
          • Melissa Baer
        • Principal Investigator:
          • Caceres Tamar, MD
    • Missouri
      • Columbia, Missouri, United States, 65211
        • Recruiting
        • University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders
        • Principal Investigator:
          • David Berversdorf, MD
        • Contact:
          • Nicole Takahashi
    • New Mexico
      • Alamogordo, New Mexico, United States, 88210
        • Withdrawn
        • Golden Hearts Diagnostic
    • Texas
      • Houston, Texas, United States, 77090
        • Withdrawn
        • Red Oak Psychiatry Associates
    • Utah
      • Clinton, Utah, United States, 84015
        • Recruiting
        • Alpine Research Organization
        • Contact:
          • Amy Kenley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male or female individuals with an autism diagnosis as defined by the DSM-5, adults (from 18 to 65 years of age, inclusive) and adolescents (from 12 to 17 years of age, inclusive).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0
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.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stalicla SA

Investigators

  • Study Director: Paulo Fontoura, MD, PhD, Stalicla SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2022

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STA-B-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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