A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)

  • Neurodevelopmental Disorder
  • Autism Spectrum Disorder
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Canada
  • United Kingdom
  • United States
Trial Identifier:

NCT03611075 BP40331

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This is a non-drug study seeking to characterize different scales to measure repetitive and restrictive behaviors in different ASD sub-populations over time. This study will also explore the use of digital biomarkers.

      Hoffmann-La Roche Sponsor
      NCT03611075,BP40331,2019-003524-20 Trial Identifier
      No Intervention Treatments
      Autism Spectrum Disorder Condition
      Official Title

      Study to Evaluate and Explore Scales for Repetitive and Restricted Behaviors and Digital Biomarkers in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)

      Eligibility Criteria

      All Gender
      ≥ 5 Years & ≤ 45 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria

      Inclusion Criteria for All Participants

      • Males and females
      • Availability of a parent or other reliable caregiver. The same person must agree to accompany the participant to all clinic visits and provide information about the participant's behavior and symptoms

      Inclusion Criteria for Participants with Autism Spectrum Disorders (ASD)(Diagnostic evaluations will be completed at study site by research staff and supervised by a licensed psychologist)

      • Age: 5-45 years
      • Diagnosis of ASD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and the Autism Diagnostic Observation Schedule (ADOS-2).
      • Children's Yale-Brown Obsessive Compulsive Scale modified for ASD (CY-BOCS-ASD) total score of at least 12
      • Clinical Global Impression-Severity (CGI-S) scale of at least 4 about participant's current autism severity
      • Intelligence quotient (IQ) score of 50 or above as assessed by the Abbreviated Intelligence Quotient (ABIQ) SB5 scale
      • All medications and treatments are expected to be stable for the duration of the study

      Inclusion Criteria for Typically Developing (TD) Healthy Participants

      • TD participants aged 5-45 years
      Exclusion Criteria

      Exclusion Criteria for All Participants

      • Participation in an in investigational drug or device study within 4 weeks or 5 times the half-life of the investigational molecule prior to screening, and participant is not expected to enroll in any other trial during the study
      • Co-occurring disease, condition, or treatment that might interfere with the conduct of the study or pose an unacceptable risk to the participant
      • Unstable or uncontrolled clinically significant psychiatric and/or neurological disorder that may interfere with study objectives

      Exclusion Criteria for Participants with ASD -Known "syndromic" ASD (e.g. Fragile X syndrome, Angelman syndrome, Prader-Willi, Rett's syndrome, tuberous sclerosis, Dup15q syndrome) History of alcohol misuse and/or illicit drug use during the last 12 months of the study

      Exclusion Criteria for TD Healthy Participants

      • TD healthy participants with a first-degree relative with ASD

      For the latest version of this information please go to www.forpatients.roche.com

       

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