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

Stalicla

Status: Enrolling

Conditions: Autism Spectrum Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT05590715

STA-B-001

Details and patient eligibility

About

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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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.