Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

NCT ID: NCT04273087

Last Updated: 2022-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-04

Study Completion Date

2022-10-31

Brief Summary

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

Detailed Description

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Conditions

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Autism Spectrum Disorder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Observation

Clinical signs and symptoms

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stalicla SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig A Erickson, MD

Role: PRINCIPAL_INVESTIGATOR

CCHMC

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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STP1-C003

Identifier Type: -

Identifier Source: org_study_id

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