Autism Spectrum Disorder
Conditions
Brief summary
To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication
Interventions
None listed
Sponsors
Stalicla SA
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations. | 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 | Day 0 | Better characterize subpopulations of ASD subjects and potentially identify/confirm a molecular signature specific of each subpopulation. |
Countries
Australia, Spain, United States
Contacts
CONTACTEric Painbeni, PhD
STUDY_DIRECTORPaulo Fontoura, MD, PhD
Stalicla SA
Outcome results
None listed