Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

Stalicla

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Other: Observation

Study type: Observational

Funder types: Industry

Identifiers

NCT04273087

STP1-C003

Details and patient eligibility

About

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

Enrollment: 236 patients

Sex: All

Ages: 10 to 40 years old

Volunteers: No 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 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