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Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04273087
Enrollment
236
Registered
2020-02-17
Start date
2020-06-04
Completion date
2022-10-31
Last updated
2022-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

Interventions

OTHERObservation

Clinical signs and symptoms

Sponsors

Stalicla SA
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD)Day 0A questionnaire will be administered to collect non-behavioral traits and co-occurring conditions data of the participants

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026