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NCT04600882 Clinical Trial

Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:
Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder (ASD)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04600882
Other study ID # STP1-C002
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 30, 2020
Est. completion date April 30, 2021

Study information
Verified date August 2022
Source Stalicla SA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 30, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Stalicla SA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD) A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants Day 0
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