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Characterization of a Clinical Subpopulation 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.
 
ClinicalTrials.gov Identifier: NCT04273087
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Stalicla SA

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

Condition or disease Intervention/treatment
Autism Spectrum Disorder Other: Observation

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Characterization of a Clinical Subpopulation With Autism Spectrum Disorder
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Observation
    Clinical signs and symptoms


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

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Ages Eligible for Study:   10 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cincinnati Children's Hospital Primary Care Clinic
Criteria

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

Non-Inclusion 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 ClinicalTrials.gov identifier (NCT number): NCT04273087


Contacts
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Contact: Olivia Walter 513.636.9373 Olivia.Walter@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Craig A Erickson, MD    513-803-8653    autism@cchmc.org   
Sponsors and Collaborators
Stalicla SA
Investigators
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Principal Investigator: Craig A Erickson, MD CCHMC
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Responsible Party: Stalicla SA
ClinicalTrials.gov Identifier: NCT04273087    
Other Study ID Numbers: STP1-C003
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: November 3, 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
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders