Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder

Stalicla

Status: Withdrawn

Conditions: Autism Spectrum Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT04600882

STP1-C002

Details and patient eligibility

About

This single-center, observational study is being conducted to identify a well-characterized subgroup within the ASD patient population, based on clinical symptoms and biosample analysis.

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously diagnosed with ASD (based on DSM-5 criteria and supported by either ADI-R or ADOS-2 scores)
• At least two well documented head circumference values recorded within the first 2 years of life
• Participants must have a parent or reliable caregiver who agrees to provide information about the participant as required by the protocol and should be fluent in English

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