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Trial record 1 of 1 for:    NCT04600882
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Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04600882
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : November 17, 2020
Information provided by (Responsible Party):
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.

Condition or disease
Autism Spectrum Disorder

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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder (ASD)
Estimated Study Start Date : November 30, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD) [ Time Frame: Day 0 ]
    A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Nationwide Children's Hospital Primary Care Clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04600882

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Contact: Aria Harter (614) 722-0723

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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Daniel Coury, MD, FAAP    614-722-2435   
Principal Investigator: Daniel Coury, MD, FAAP         
Sponsors and Collaborators
Stalicla SA
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Responsible Party: Stalicla SA Identifier: NCT04600882    
Other Study ID Numbers: STP1-C002
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stalicla SA:
autism spectrum disorder
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders