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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05590715
• Other study ID #: STA-B-001
• Status: Recruiting
• Start date: October 13, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Stalicla SA
• Contact: Gregory Bonfils, PhD
• Phone: +41 22 545 12 42
• Email: gregory.bonfils[@]stalicla.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Locations

Country	Name	City	State
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Murdoch Children's Research Institute	Parkville	Victoria
Australia	Children's Health Queensland Hospital and Health Service	South Brisbane	Queensland
Australia	Mater Misericordiae Limited	South Brisbane	Queensland
Spain	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	Hospital Universitari Son Espases (HUSE) - Institut Balear per a la Salut Mental de la Infancia i l'Adolescencia (IBSMIA)	Palma De Mallorca
Spain	Policlina Gipuzkoa	San Sebastián
Spain	Hospital Álvaro Cunqueiro_	Vigo
United States	Golden Hearts Diagnostic	Alamogordo	New Mexico
United States	Rush University Medical Center	Chicago	Illinois
United States	Alpine Research Organization	Clinton	Utah
United States	University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders	Columbia	Missouri
United States	Red Oak Psychiatry Associates	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Stalicla SA

Countries where clinical trial is conducted

United States,  Australia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations.	A semi-structured medical questionnaire will be administered to collect clinical (sign and symptoms) and anthropomorphic features.	Day 0
Primary	Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations	Better characterize subpopulations of ASD subjects and potentially identify/confirm a molecular signature specific of each subpopulation.	Day 0