NCT05590715

Brief Summary

To determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
3 countries

21 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2022May 2027

Study Start

First participant enrolled

October 13, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

April 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

October 18, 2022

Last Update Submit

April 24, 2026

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Day 0

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

SARRC

Phoenix, Arizona, 85006, United States

RECRUITING

California Neuroscience Research

Sherman Oaks, California, 91403, United States

RECRUITING

BioPhase Research

Miami, Florida, 33137, United States

TERMINATED

The Angel Medical Research

Miami Lakes, Florida, 33016, United States

WITHDRAWN

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders

Columbia, Missouri, 65211, United States

RECRUITING

Golden Hearts Diagnostic

Alamogordo, New Mexico, 88210, United States

WITHDRAWN

Red Oak Psychiatry Associates

Houston, Texas, 77090, United States

WITHDRAWN

Alpine Research Organization

Clinton, Utah, 84015, United States

RECRUITING

Children's Health Queensland Hospital and Health Service

South Brisbane, Queensland, 4101, Australia

NOT YET RECRUITING

Mater Misericordiae Limited

South Brisbane, Queensland, 4101, Australia

NOT YET RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

NOT YET RECRUITING

Locuspsych

Melbourne, Victoria, 3004, Australia

RECRUITING

Murdoch Children's Research Institute

Parkville, Victoria, 3052, Australia

NOT YET RECRUITING

Hospital General Universitario Dr Balmis

Alicante, 30010, Spain

RECRUITING

Hospital Clinic of Barcelona

Barcelona, 8036, Spain

RECRUITING

Hospital Infantil Universitario Nino Jesus (HIUNJS)

Madrid, 28009, Spain

RECRUITING

Hospital universitario Infanta Leonor

Madrid, 28031, Spain

RECRUITING

Hospital Universitario Puerta De Hierro Majadahonda

Majadahonda, 28222, Spain

TERMINATED

Policlina Gipuzkoa

San Sebastián, 20014, Spain

ACTIVE NOT RECRUITING

Hospital Álvaro Cunqueiro

Vigo, 36213, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA and RNA extraction, plasma and PBMC isolation.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Paulo Fontoura, MD, PhD

    Stalicla SA

    STUDY DIRECTOR

Central Study Contacts

Eric Painbeni, PhD

CONTACT

+41 22 545 12 42clinical@stalicla.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 21, 2022

Study Start

October 13, 2022

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

April 27, 2026

Record last verified: 2026-02

Locations

AU(5)US(9)ES(7)