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International Multicentric Observational Study to Characterize Subpopulations of Patients

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

Condition(s)Autism Spectrum Disorder
StatusRecruiting
Study typeObservational
SummaryTo determine sufficient number of biological and clinical markers to identify subgroups of potential best responders to a specific medication
Who can participateInclusion 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.
Ages12 Years to 65 Years
SexAll
Lead sponsorStalicla SA
LocationsPhoenix, Arizona, United States; Sherman Oaks, California, United States; Miami, Florida, United States; Miami Lakes, Florida, United States; Chicago, Illinois, United States; Columbia, Missouri, United States (+15 more sites)
Start date2022-10-13
NCT IDNCT05590715
Official listinghttps://clinicaltrials.gov/study/NCT05590715

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