Characterization of a Clinical Subpopulation With Autism... | NCT04273087

Studies
Characterization of a Clinical Subpopulation With Autism Spectrum Disorder

NCT04273087

Sponsor

Stalicla SA

Status

Completed

Last Update Posted

Nov 18, 2022Actual

Enrollment

236Actual

Phase

Not provided

Conditions

Autism Spectrum Disorder

Interventions

Observation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2020Actual

Primary Completion Date

Oct 31, 2022Actual

Completion Date

Oct 31, 2022Actual

First Submitted Date

Feb 6, 2020

First Submission Date that Met QC Criteria

Feb 14, 2020

First Posted Date

Feb 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2022

Last Update Posted Date

Nov 18, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

236Actual

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Clinical signs and symptoms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Cincinnati Children's Hospital Primary Care Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Craig A Erickson, MD	CCHMC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45229	United States

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided