Autism Spectrum DisorderNCT05590715
International Multicentric Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Stalicla SA at 21 sites in 3 countries.
Trial summary
To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 1,500 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 13 Oct 2022to 31 May 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male or female individuals with an autism diagnosis as defined by the DSM-5, adults (from 18 to 65 years of age, inclusive) and adolescents (from 12 to 17 years of age, inclusive).
Who may be able to join
- Participants previously diagnosed with ASD (DSM-5)
- Available well-documented 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
- Participants willing and consenting or assenting to participate.
Who cannot join
- Episode of fever (i.e. ≥100.5 °F or ≥ 38 °C) or clinically significant illness without fever (as judged by the investigator), within 10 days before any study assessment.
- If the investigator assesses any unwillingness or any medical condition that may prevent the subject from completing this study.
Trial locations and contacts
21 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 3 countries
United States9 sites, 5 recruiting
- Withdrawn
Golden Hearts Diagnostic
Alamogordo, New Mexico, 88210
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Melissa Baer
Caceres Tamar, MD
- Recruiting
Alpine Research Organization
Clinton, Utah, 84015
Amy Kenley
- Recruiting
University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders
Columbia, Missouri, 65211
Nicole Takahashi
David Berversdorf, MD
- Withdrawn
Red Oak Psychiatry Associates
Houston, Texas, 77090
- Terminated
BioPhase Research
Miami, Florida, 33137
- Withdrawn
The Angel Medical Research
Miami Lakes, Florida, 33016
- Recruiting
SARRC
Phoenix, Arizona, 85006
Riley Stark, 480-351-0567, rstark@autismcenter.org
- Recruiting
California Neuroscience Research
Sherman Oaks, California, 91403
Jessica Vuong, 818-990-2671, j.vuong@cenexel.com
Spain7 sites, 5 recruiting
- Recruiting
Hospital General Universitario Dr Balmis
Alicante, 30010
Maria Auxiliadora Javaloyes Sanchis, MD
Maria Auxiliadora Javaloyes Sanchis, MD
- Recruiting
Hospital Clinic of Barcelona
Barcelona, 8036
Rosa Calvo Escalona, MD/PhD
Rosa Calvo Escalona, MD/PhD
- Recruiting
Hospital Infantil Universitario Nino Jesus (HIUNJS)
Madrid, 28009
Silvia Gutierrez Priego, MD
Silvia Gutierrez Priego, MD
- Recruiting
Hospital universitario Infanta Leonor
Madrid, 28031
Francisco Javier Quintero Gutiérrez del Álamo, MD/PhD
Francisco Javier Quintero Gutiérrez del Álamo, MD/PhD
- Terminated
Hospital Universitario Puerta De Hierro Majadahonda
Majadahonda, 28222
- Active, not recruiting
Policlina Gipuzkoa
San Sebastián, 20014
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, 36213
Jose Manuel Olivares Diez, MD/PhD
Jose Manuel Olivares Diez, MD/PhD
Australia5 sites, 5 recruiting
- Not yet recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Rupali Saikia
- Recruiting
Locuspsych
Melbourne, Victoria, 3004
Ahmad Torshizi, M.D., Admin@drtorshizi.com
- Not yet recruiting
Murdoch Children's Research Institute
Parkville, Victoria, 3052
Kylie Crompton
- Not yet recruiting
Children's Health Queensland Hospital and Health Service
South Brisbane, Queensland, 4101
Emily Milburn
- Not yet recruiting
Mater Misericordiae Limited
South Brisbane, Queensland, 4101
Caitlin Bennett
About this study
Official title: International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication
- Conditions
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations.
A semi-structured medical questionnaire will be administered to collect clinical (sign and symptoms) and anthropomorphic features.
Measured: Day 0
Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations
Better characterize subpopulations of ASD subjects and potentially identify/confirm a molecular signature specific of each subpopulation.
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 posted21 Oct 2022
- Study start13 Oct 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Stalicla SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paulo Fontoura, MD, PhD, Study director, Stalicla SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590715
- Sponsor's protocol ID
- STA-B-001
- Status last verified
- Feb 2026
- First submitted
- 18 Oct 2022
- Last updated
- 27 Apr 2026
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05590715
- Acronym / sponsor ID
- STA-B-001
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Stalicla SAIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 21 Oct 2022 (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.
To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female individuals with an autism diagnosis as defined by the DSM-5, adults (from 18 to 65 years of age, inclusive) and adolescents (from 12 to 17 years of age, inclusive).
Key inclusion criteria (4 listed)
- Participants previously diagnosed with ASD (DSM-5)
- Available well-documented 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
- Participants willing and consenting or assenting to participate.
Key exclusion criteria (2 listed)
- Episode of fever (i.e. ≥100.5 °F or ≥ 38 °C) or clinically significant illness without fever (as judged by the investigator), within 10 days before any study assessment.
- If the investigator assesses any unwillingness or any medical condition that may prevent the subject from completing this study.
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
Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations.
Time frame: Day 0
A semi-structured medical questionnaire will be administered to collect clinical (sign and symptoms) and anthropomorphic features.
Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations
Time frame: Day 0
Better characterize subpopulations of ASD subjects and potentially identify/confirm a molecular signature specific of each subpopulation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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.
Paulo Fontoura, MD, PhD study director
Stalicla SA
21 sites in 3 countries: 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 21 sites in 3 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Spain, Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Painbeni, PhD (+41 22 545 12 42, clinical@stalicla.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations. (time frame: Day 0). The study lists 2 primary outcomes in all. 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 27 Apr 2026.