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Withdrawn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
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- WITHDRAWN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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States