Observational study to identify subgroups of patients with Autism Spectrum Disorder
International, Multicentric, Observational Study to Characterize Subpopulations of Patients With Autism Spectrum Disorder
This study is trying to find different groups of people with Autism Spectrum Disorder to see which ones might respond best to certain medications based on their unique traits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | Stalicla SA Industry-sponsored |
| Locations | 21 sites (Phoenix, Arizona and 20 other locations) |
| Trial ID | NCT05590715 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize subpopulations of patients diagnosed with Autism Spectrum Disorder (ASD) by identifying biological and clinical markers that may indicate which individuals are likely to respond best to specific medications. Participants will include individuals with a documented diagnosis of ASD and health records from early childhood. The study will gather data from multiple locations to ensure a diverse participant pool and enhance the reliability of findings.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Autism Spectrum Disorder who have accessible health records from the first two years of life.
Not a fit: Patients who have had a recent significant illness or fever, or those unable to complete the study due to medical conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for individuals with Autism Spectrum Disorder.
How similar studies have performed: While this approach is observational and aims to identify subpopulations, similar studies have shown promise in understanding ASD and tailoring treatments, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Phoenix, Arizona and 20 other locations
- Sarrc — Phoenix, Arizona, United States (Recruiting)
- California Neuroscience Research — Sherman Oaks, California, United States (Recruiting)
- BioPhase Research — Miami, Florida, United States (Terminated)
- The Angel Medical Research — Miami Lakes, Florida, United States (Withdrawn)
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Missouri, Thompson Center for Autism & Neurodevelopmental Disorders — Columbia, Missouri, United States (Recruiting)
- Golden Hearts Diagnostic — Alamogordo, New Mexico, United States (Withdrawn)
- Red Oak Psychiatry Associates — Houston, Texas, United States (Withdrawn)
- Alpine Research Organization — Clinton, Utah, United States (Recruiting)
- Children's Health Queensland Hospital and Health Service — South Brisbane, Queensland, Australia (Not_yet_recruiting)
- Mater Misericordiae Limited — South Brisbane, Queensland, Australia (Not_yet_recruiting)
- Flinders Medical Centre — Bedford Park, South Australia, Australia (Not_yet_recruiting)
- Locuspsych — Melbourne, Victoria, Australia (Recruiting)
- Murdoch Children's Research Institute — Parkville, Victoria, Australia (Not_yet_recruiting)
- Hospital General Universitario Dr Balmis — Alicante, Spain (Recruiting)
- Hospital Clinic of Barcelona — Barcelona, Spain (Recruiting)
- Hospital Infantil Universitario Nino Jesus (HIUNJS) — Madrid, Spain (Recruiting)
- Hospital universitario Infanta Leonor — Madrid, Spain (Recruiting)
- Hospital Universitario Puerta De Hierro Majadahonda — Majadahonda, Spain (Terminated)
- Policlina Gipuzkoa — San Sebastián, Spain (Active_not_recruiting)
- Hospital Álvaro Cunqueiro — Vigo, Spain (Recruiting)
Study contacts
- Study coordinator: Eric Painbeni, PhD
- Email: clinical@stalicla.com
- Phone: +41 22 545 12 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.