Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

Stalicla SA1 site in 1 country236 target enrollmentJune 4, 2020

ConditionsAutism Spectrum Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Autism Spectrum Disorder
Sponsor: Stalicla SA
Enrollment: 236
Locations: 1
Primary Endpoint: Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.

Registry

clinicaltrials.gov

Start Date

June 4, 2020

End Date

October 31, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Stalicla SA

Responsible Party

Sponsor

Eligibility Criteria

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 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

Exclusion Criteria

•Genetically identified ASD (syndromic form of autism, e.g. fragile X)
•Episode of fever (i.e. ≥100.5 °F) or clinically significant illness without fever (as judged by the Investigator), within 10 days before the study visit