Clinical trial NCT05590715: International Multicentric Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
Official title: International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Lead sponsor: Stalicla SA
Sponsor class: INDUSTRY
First posted: 2022-10-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations.
timeFrame: Day 0
measure: Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: SARRC
state: Arizona
city: Sherman Oaks
country: United States
facility: California Neuroscience Research
state: California
city: Miami Lakes
country: United States
facility: The Angel Medical Research
state: Florida
city: Miami
country: United States
facility: BioPhase Research
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Columbia
country: United States
facility: University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders
state: Missouri
city: Alamogordo
country: United States
facility: Golden Hearts Diagnostic
state: New Mexico
city: Houston
country: United States
facility: Red Oak Psychiatry Associates
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization
state: Utah
city: South Brisbane
country: Australia
facility: Children's Health Queensland Hospital and Health Service
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: Locuspsych
state: Victoria
city: Parkville
country: Australia
facility: Murdoch Children's Research Institute
state: Victoria
city: Alicante
country: Spain
facility: Hospital General Universitario Dr Balmis
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus (HIUNJS)
city: Madrid
country: Spain
facility: Hospital universitario Infanta Leonor
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta De Hierro Majadahonda
city: San Sebastián
country: Spain
facility: Policlina Gipuzkoa
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
affiliation: Stalicla SA
name: Paulo Fontoura, MD, PhD
role: STUDY_DIRECTOR
References: