Autism Spectrum DisorderNCT04600882
Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Stalicla SA at 1 site in United States.
Trial summary
This single-center, observational study is being conducted to identify a well-characterized subgroup within the ASD patient population, based on clinical symptoms and biosample analysis. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 30 Apr 2021
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Nationwide Children's Hospital Primary Care Clinic
Who may be able to join
- Previously diagnosed with ASD (based on DSM-5 criteria and supported by either ADI-R or ADOS-2 scores)
- At least two well documented head circumference values recorded within the first 2 years of life
- Participants must have a parent or reliable caregiver who agrees to provide information about the participant as required by the protocol and should be fluent in English
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
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder (ASD)
This single-center, observational study is being conducted to identify a well-characterized subgroup within the ASD patient population, based on clinical symptoms and biosample analysis.
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, endophenotyping, observational
- Medical subject headings
- Autism Spectrum Disorder
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 posted23 Oct 2020
- Study start30 Nov 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Why it stopped: No subjects enrolled
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
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stalicla SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600882
- Sponsor's protocol ID
- STP1-C002
- Status last verified
- Aug 2022
- First submitted
- 19 Oct 2020
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of a Clinical Subpopulation in Children With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT04600882
- Acronym / sponsor ID
- STP1-C002
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, endophenotyping, observational
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stalicla SAIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 23 Oct 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.
This single-center, observational study is being conducted to identify a well-characterized subgroup within the ASD patient population, based on clinical symptoms and biosample analysis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Nationwide Children's Hospital Primary Care Clinic
Key inclusion criteria (3 listed)
- Previously diagnosed with ASD (based on DSM-5 criteria and supported by either ADI-R or ADOS-2 scores)
- At least two well documented head circumference values recorded within the first 2 years of life
- Participants must have a parent or reliable caregiver who agrees to provide information about the participant as required by the protocol and should be fluent in English
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.
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
The record lists no contact. Use the official record to reach the sponsor.
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: withdrawn, as of the sponsor's last update on 31 Aug 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 was withdrawn before enrolling participants, so there are no results.
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 31 Aug 2022.