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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stalicla SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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