Phase 1
N=144
A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03611075 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Children's Yale-Brown Obsessive Compulsive Scale Modified for Autism Spectrum Disorder (CY-BOCS-ASD) - Total Score — 14.81; 14.60; 14.94; 15.71 Score on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- No Intervention (Other)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Yale-Brown Obsessive Compulsive Scale Modified for Autism Spectrum Disorder (CY-BOCS-ASD) - Total Score |
14.81; 14.60; 14.94; 15.71; 15.23; 15.83 | — |
| PRIMARY Montefiore Einstein Rigidity Scale (MERS-R) |
29.88; 25.67; 22.56; 28.35; 25.46; 25.78 | — |
| PRIMARY Repetitive Behavior Scale-Revised (RBS-R) |
39.81; 38.29; 33.06; 56.82; 38.25; 42.67 | — |
| PRIMARY Repetitive Behavior Questionnaire for Children (RBQ-2) |
38.63; 35.57; 34.50; 41.76; 38.00; 39.14 | — |
| PRIMARY Restricted Behavior Questionnaire for Adults (RBQ-2A) |
36.29; 39.00; 35.50; 40.73; 38.25; 41.86 | — |
| PRIMARY Childhood Routines Inventory-Revised (CRI-R) |
177.38; 174.50; 166.25; 187.69; 164.33; 171.21 | — |
| PRIMARY Adult Routines Inventory (ARI) |
142.50; 166.00; 165.00; 158.07; 137.00; 164.00 | — |
| SECONDARY Clinical Global Impression Scales (CGI) |
4.63; 4.47; 4.56; 5.18; 5.69; 4.89 | — |
| SECONDARY Child's Sleep Habits Questionnaire (CSHQ) |
54.00; 48.08; 42.73; 48.31; 41.45; 40.33 | — |
| SECONDARY Pittsburg Sleep Quality Index (PSQI) |
6.00; 7.67; 2.00; 6.69; 6.33; 6.60 | — |
| SECONDARY Reading the Mind in the Eyes Test -R (RMET-R) |
15.44; 21.45; 12.00; 15.63; 19.22; 10.67 | — |
| SECONDARY Reading the Mind in the Eyes Test Child -C (RMET-C) |
16.64; 16.25; 12.67; 11.00; 14.33; 15.00 | — |
| SECONDARY Hamilton Anxiety Rating Scale (HAM-A) |
10.81; 11.00; 11.46; 7.19; 9.92; 6.25 | — |
| SECONDARY Parent Rated Anxiety Scale for ASD (PRAS-ASD) |
33.94; 28.50; 29.12; 21.92; 29.38; 29.15 | — |
| SECONDARY Beck Anxiety Index (BAI) |
17.21; 19.64; 16.00; 13.47; 12.08; 15.50 | — |
| SECONDARY Digital Biomarkers |
10; 12; 13; 7; 11; 6 | — |
| SECONDARY Behaviour Rating Inventory of Executive Function for Children (BRIEF) |
203.63; 189.50; 196.47; 184.08; 197.13; 196.15 | — |
| SECONDARY Behaviour Rating Inventory of Executive Function for Adults (BRIEF-A) |
150.06; 153.35; 149.67; 156.83; 152.43; 157.61 | — |
| SECONDARY Short Sensory Profile (SSP) |
125.75; 132.86; 122.44; 138.73; 128.19; 129.15 | — |
| SECONDARY Vineland(TM)-II Survey |
73.88; 75.07; 60.09; 69.41; 64.35; 44.86 | — |
| SECONDARY Pediatric Quality of Life Inventory (PedsQL) Family Impact Scale |
50.78; 52.58; 67.45; 54.13; 54.11; 63.44 | — |
| SECONDARY PedsQL Core Functioning Scale |
55.98; 64.22; 64.78; 61.78; 76.96; 62.44 | — |
| SECONDARY PedsQL Cognitive Functioning Scale |
50.78; 52.58; 67.45; 54.13; 54.11; 63.44 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03611075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.