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
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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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