Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04273087
• Other study ID #: STP1-C003
• Status: Completed
• Start date: June 4, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Stalicla SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 40 Years

Eligibility

Inclusion Criteria:

• Participants previously diagnosed with ASD (DSM-5) supported by either autism diagnostic interview revised (ADI-R) or Autism Diagnostic Observation Scale (ADOS-2) scores

• Available 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

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• Observation
Clinical signs and symptoms

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	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