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

Sponsor

Stalicla SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05590715

Collaborator

(none)

1,500

Enrollment

Locations

21.6

Anticipated Duration (Months)

125

Patients Per Site

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 13, 2022

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants previously diagnosed with ASD (DSM-5) supported by either autism diagnostic interview revised (ADI-R) or Autism Diagnostic Observation Scale (ADOS-2) scores
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612
2	University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders	Columbia	Missouri	United States	65211
3	Red Oak Psychiatry Associates	Houston	Texas	United States	77090
4	Texas Child Neurology	Plano	Texas	United States	75024
5	Hospital General Universitario Dr Balmis	Alicante		Spain	30010
6	Hospital Clinic of Barcelona	Barcelona		Spain	8036
7	Hospital Infantil Universitario Nino Jesus (HIUNJS)	Madrid		Spain	28009
8	Hospital universitario Infanta Leonor	Madrid		Spain	28031
9	Hospital Universitario Puerta De Hierro Majadahonda	Majadahonda		Spain	28222
10	Hospital Universitari Son Espases (HUSE) - Institut Balear per a la Salut Mental de la Infancia i l'Adolescencia (IBSMIA)	Palma De Mallorca		Spain	7120
11	Hospital Álvaro Cunqueiro	Vigo		Spain	36213
12	Complejo asistencial de Zamora, Hospital Provincial	Zamora		Spain	49071

Sponsors and Collaborators

Stalicla SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stalicla SA

ClinicalTrials.gov Identifier:

NCT05590715

Other Study ID Numbers:

STA-B-001

First Posted:

Oct 21, 2022

Last Update Posted:

Jan 20, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Autistic Disorder

Autism Spectrum Disorder

Child Development Disorders, Pervasive

Study Results

No Results Posted as of Jan 20, 2023