Characterizing Subpopulations for Autism Spectrum Disorder

Recruiting at 18 trial locations

Overseen By Gregory Bonfils, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stalicla SA

Disqualifiers: Fever, Significant illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify groups of people with Autism Spectrum Disorder (ASD) who might benefit most from a specific medication in the future. Researchers seek biological and clinical markers to help classify these subgroups. Participants must have an existing ASD diagnosis and detailed health records from their first two years of life. Additionally, a parent or reliable caregiver must be available to provide information. This study involves no treatment, focusing solely on observation and data collection. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could shape future ASD treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

Why are researchers excited about this trial?

This trial is unique because it focuses on understanding the different subpopulations within individuals diagnosed with Autism Spectrum Disorder (ASD), rather than testing a specific treatment. Researchers are excited about this approach because it could lead to more personalized and effective treatment strategies in the future. By identifying distinct subgroups within the ASD population, this study may help tailor interventions to better meet the needs of each individual, potentially improving outcomes compared to the current one-size-fits-all approach.

Who Is on the Research Team?

Paulo Fontoura, MD, PhD

Principal Investigator

Stalicla SA

Are You a Good Fit for This Trial?

Inclusion Criteria

Available well-documented health records within the first 2 years of life

Participants previously diagnosed with ASD (DSM-5) supported by either autism diagnostic interview revised (ADI-R) or Autism Diagnostic Observation Scale (ADOS-2) scores

Participants must have a parent or reliable caregiver who agrees to provide information about the participant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants undergo clinical and molecular characterization to identify subpopulations

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after observation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• N/A

Who Is Running the Clinical Trial?

Stalicla SA

Lead Sponsor

Trials

5

Recruited

1,800+