Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05590715




Registration number
NCT05590715
Ethics application status
Date submitted
18/10/2022
Date registered
21/10/2022
Date last updated
20/08/2024

Titles & IDs
Public title
International Multicentric Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
Scientific title
International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
Secondary ID [1] 0 0
STA-B-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations.
Timepoint [1] 0 0
Day 0
Primary outcome [2] 0 0
Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations
Timepoint [2] 0 0
Day 0

Eligibility
Key inclusion criteria
* 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.
Minimum age
12 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Children's Health Queensland Hospital and Health Service - South Brisbane
Recruitment hospital [2] 0 0
Mater Misericordiae Limited - South Brisbane
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Locuspsych - Melbourne
Recruitment hospital [5] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
New Mexico
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah
Country [7] 0 0
Spain
State/province [7] 0 0
Alicante
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Spain
State/province [10] 0 0
Majadahonda
Country [11] 0 0
Spain
State/province [11] 0 0
San Sebastián
Country [12] 0 0
Spain
State/province [12] 0 0
Vigo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Stalicla SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication
Trial website
https://clinicaltrials.gov/study/NCT05590715
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph Palumbo, MD
Address 0 0
Stalicla SA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gregory Bonfils, PhD
Address 0 0
Country 0 0
Phone 0 0
+41 22 545 12 42
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05590715