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CompletedNCT04273087Updated Nov 18, 2022

Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

An observational study in Autism Spectrum Disorder, sponsored by Stalicla SA. Completed at 1 site in United States. Open to participants aged 10 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by Stalicla SA · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
236
Ages
10 Years to 40 Years
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 236 is above the median of 102 across 267 observational studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Stalicla SA is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cincinnati Children's Hospital Primary Care Clinic

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
236 participants (actual)
Patient registry
No

Interventions

  • OtherObservation

    Clinical signs and symptoms

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 0

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Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04273087
Lead sponsor
Stalicla SA
Responsible party
Sponsor
First posted
Feb 17, 2020
Start date
Jun 4, 2020
Primary completion
Oct 31, 2022
Completion
Oct 31, 2022
Last update
Nov 18, 2022

Study contacts

Craig A Erickson, MD
principal investigator · CCHMC

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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