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

Roche

Status and phase: Completed; Phase 1

Conditions: Autism Spectrum Disorder

Treatments: Other: No Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT03611075

2019-003524-20 (EudraCT Number)

BP40331

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 5 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 9 patient groups

Low-Functioning Autism Spectrum Disorder (ASD) Children

Experimental group

Description:

Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70

Treatment:

Other: No Intervention

High-Functioning ASD Children

Experimental group

Description:

Participants will be 5-12 years old, with IQ scores of 70 or above

Treatment:

Other: No Intervention

Low-Functioning ASD Adolescents

Experimental group

Description:

Participants will be 13-17 years old, with IQ scores between 50-70

Treatment:

Other: No Intervention

High-Functioning ASD Adolescents

Experimental group

Description:

Participants will be 13-17 years old, with IQ scores of 70 or above

Treatment:

Other: No Intervention

Low-Functioning ASD Adults

Experimental group

Description:

Participants will be 18-45 years old, with IQ scores between 50-70

Treatment:

Other: No Intervention

High-Functioning ASD Adults

Experimental group

Description:

Participants will be 18-45 years old, with IQ scores of 70 or above

Treatment:

Other: No Intervention

Typically Developing (TD) Healthy Participant Children

No Intervention group

Description:

Participants will be 5-12 years old

TD Healthy Participant Adolescents

No Intervention group

Description:

Participants will be 13-17 years old

TD Healthy Participant Adults

No Intervention group

Description:

Participants will be 18-45 years old