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OpenTrials
Completed

NCT Number: NCT04273087

Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

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

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

10 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

Clinical signs and symptoms

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Stalicla SA

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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