Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder

NCT ID: NCT04600882

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-04-30

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stalicla SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Other Identifiers

STP1-C002

Identifier Type: -

Identifier Source: org_study_id