1500 Participants Needed

International Multicentric Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder

Recruiting at 18 trial locations
EP
GB
Overseen ByGregory Bonfils, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Stalicla SA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

Research Team

PF

Paulo Fontoura, MD, PhD

Principal Investigator

Stalicla SA

Eligibility Criteria

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
See 1 more

Timeline

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

Treatment Details

Interventions

  • N/A

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stalicla SA

Lead Sponsor

Trials
5
Recruited
1,800+
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