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

NCT ID: NCT05590715

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-13

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stalicla SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paulo Fontoura, MD, PhD

Role: STUDY_DIRECTOR

Stalicla SA

Locations

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SARRC

Phoenix, Arizona, United States

Site Status RECRUITING

California Neuroscience Research

Sherman Oaks, California, United States

Site Status RECRUITING

BioPhase Research

Miami, Florida, United States

Site Status TERMINATED

The Angel Medical Research

Miami Lakes, Florida, United States

Site Status WITHDRAWN

Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders

Columbia, Missouri, United States

Site Status RECRUITING

Golden Hearts Diagnostic

Alamogordo, New Mexico, United States

Site Status WITHDRAWN

Red Oak Psychiatry Associates

Houston, Texas, United States

Site Status WITHDRAWN

Alpine Research Organization

Clinton, Utah, United States

Site Status RECRUITING

Children's Health Queensland Hospital and Health Service

South Brisbane, Queensland, Australia

Site Status NOT_YET_RECRUITING

Mater Misericordiae Limited

South Brisbane, Queensland, Australia

Site Status NOT_YET_RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, Australia

Site Status NOT_YET_RECRUITING

Locuspsych

Melbourne, Victoria, Australia

Site Status RECRUITING

Murdoch Children's Research Institute

Parkville, Victoria, Australia

Site Status NOT_YET_RECRUITING

Hospital General Universitario Dr Balmis

Alicante, , Spain

Site Status RECRUITING

Hospital Clinic of Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Infantil Universitario Nino Jesus (HIUNJS)

Madrid, , Spain

Site Status RECRUITING

Hospital universitario Infanta Leonor

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Puerta De Hierro Majadahonda

Majadahonda, , Spain

Site Status TERMINATED

Policlina Gipuzkoa

San Sebastián, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Álvaro Cunqueiro

Vigo, , Spain

Site Status RECRUITING

Countries

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United States Australia Spain

Central Contacts

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Eric Painbeni, PhD

Role: CONTACT

+41 22 545 12 42

Facility Contacts

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Riley Stark

Role: primary

(480) 351-0567

Jessica Vuong

Role: primary

818-990-2671

Melissa Baer

Role: primary

Nicole Takahashi

Role: primary

Amy Kenley

Role: primary

Emily Milburn

Role: primary

Caitlin Bennett

Role: primary

Rupali Saikia

Role: primary

Ahmad Torshizi, M.D.

Role: primary

Kylie Crompton

Role: primary

Maria Auxiliadora Javaloyes Sanchis, MD

Role: primary

Rosa Calvo Escalona, MD/PhD

Role: primary

Silvia Gutierrez Priego, MD

Role: primary

Francisco Javier Quintero Gutiérrez del Álamo, MD/PhD

Role: primary

Jose Manuel Olivares Diez, MD/PhD

Role: primary

Other Identifiers

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STA-B-001

Identifier Type: -

Identifier Source: org_study_id

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