Recruiting

Observational Study

Sponsor:

Stalicla SA

Code:

NCT05590715

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Autism Spectrum Disorder

Study ID

NCT05590715

Start date

Oct 13, 2022

Status verified date

Feb, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Clinical characterisation of the ASD-Phen1 and ASD-Phen2 subpopulations. [ Time Frame: Day 0 ]
  • Molecular characterization of the ASD-Phen1 and ASD-Phen2 subpopulations [ Time Frame: Day 0 ]

Central Contacts and Locations

Central contacts

Eric Painbeni, PhD

+41 22 545 12 42clinical@stalicla.com

Locations

SARRC

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Riley Stark

480-351-0567rstark@autismcenter.org

California Neuroscience Research

Recruiting

Sherman Oaks, California, United States, 91403

Contacts

Jessica Vuong

818-990-2671j.vuong@cenexel.com

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Caceres Tamar, MD

University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders

Recruiting

Columbia, Missouri, United States, 65211

Principal Investigator:

David Berversdorf, MD

Alpine Research Organization

Recruiting

Clinton, Utah, United States, 84015

More Information

Sponsor

Stalicla SA

Last update posted

Apr 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stalicla SA on 2026-04-27.