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

Recruiting

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT05590715
• Lead Sponsor: Stalicla SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-13
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (21)

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain

SARRC; 🇺🇸 Phoenix, Arizona, United States

California Neuroscience Research; 🇺🇸 Sherman Oaks, California, United States

The Angel Medical Research; 🇺🇸 Miami Lakes, Florida, United States

BioPhase Research; 🇺🇸 Miami, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders; 🇺🇸 Columbia, Missouri, United States

Golden Hearts Diagnostic; 🇺🇸 Alamogordo, New Mexico, United States

Red Oak Psychiatry Associates; 🇺🇸 Houston, Texas, United States

Alpine Research Organization; 🇺🇸 Clinton, Utah, United States

Children's Health Queensland Hospital and Health Service; 🇦🇺 South Brisbane, Queensland, Australia

Mater Misericordiae Limited; 🇦🇺 South Brisbane, Queensland, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Locuspsych; 🇦🇺 Melbourne, Victoria, Australia

Murdoch Children's Research Institute; 🇦🇺 Parkville, Victoria, Australia

Hospital General Universitario Dr Balmis; 🇪🇸 Alicante, Spain

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain

Hospital Infantil Universitario Nino Jesus (HIUNJS); 🇪🇸 Madrid, Spain

Hospital universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta De Hierro Majadahonda; 🇪🇸 Majadahonda, Spain

Policlina Gipuzkoa; 🇪🇸 San Sebastián, Spain