Autism Spectrum DisorderNCT04273087
Characterization of a Clinical Subpopulation With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Stalicla SA at 1 site in United States.
Trial summary
The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum. Read more about this study
- Who is it for?
- Ages 10 to 40 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Observation
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2020to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cincinnati Children's Hospital Primary Care Clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Observation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Clinical signs and symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start4 Jun 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stalicla SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig A Erickson, MD, Principal investigator, CCHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273087
- Sponsor's protocol ID
- STP1-C003
- Status last verified
- Nov 2022
- First submitted
- 6 Feb 2020
- Last updated
- 18 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of a Clinical Subpopulation With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04273087
- Acronym / sponsor ID
- STP1-C003
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Stalicla SAIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective for this research study is to gather additional information to help confirm identification of new subgroups within the autism spectrum.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cincinnati Children's Hospital Primary Care Clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationClinical signs and symptoms | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig A Erickson, MD principal investigator
CCHMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Stalicla SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of non-behavioral phenotypical traits in sub-populations with Autism Spectrum Disorder (ASD) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.