Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder

Withdrawn

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT04600882
• Lead Sponsor: Stalicla SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Study Start: 2020-11-30
• Primary Completion: 2021-03-31
• Study Completion: 2021-04-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD)	Day 0	A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States