A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)
NCT ID: NCT03611075
Last Updated: 2022-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
144 participants
INTERVENTIONAL
2018-08-13
2020-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Low-Functioning Autism Spectrum Disorder (ASD) Children
Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
No Intervention
No interventions are administered in this study
High-Functioning ASD Children
Participants will be 5-12 years old, with IQ scores of 70 or above
No Intervention
No interventions are administered in this study
Low-Functioning ASD Adolescents
Participants will be 13-17 years old, with IQ scores between 50-70
No Intervention
No interventions are administered in this study
High-Functioning ASD Adolescents
Participants will be 13-17 years old, with IQ scores of 70 or above
No Intervention
No interventions are administered in this study
Low-Functioning ASD Adults
Participants will be 18-45 years old, with IQ scores between 50-70
No Intervention
No interventions are administered in this study
High-Functioning ASD Adults
Participants will be 18-45 years old, with IQ scores of 70 or above
No Intervention
No interventions are administered in this study
Typically Developing (TD) Healthy Participant Children
Participants will be 5-12 years old
No interventions assigned to this group
TD Healthy Participant Adolescents
Participants will be 13-17 years old
No interventions assigned to this group
TD Healthy Participant Adults
Participants will be 18-45 years old
No interventions assigned to this group
Interventions
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No Intervention
No interventions are administered in this study
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
-TD participants aged 5-45 years
Exclusion Criteria
* 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
-TD healthy participants with a first-degree relative with ASD
5 Years
45 Years
ALL
Yes
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Harmonex Neuroscience Research
Dothan, Alabama, United States
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States
PCSD Feighner Research
San Diego, California, United States
Stanford University School of Medicine
Stanford, California, United States
Clinical Neuroscience Solutions Inc; Jacksonville Clinic
Jacksonville, Florida, United States
University of Minnesota; Clin. Neuro Research Unit
Minneapolis, Minnesota, United States
Nathan S. Kline Institute for Psychiatric Research
Orangeburg, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
BioBehavioral Research of Austin, PC
Austin, Texas, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Road Runner Research Ltd
San Antonio, Texas, United States
Northwest Clinical Research Center - ClinEdge - PPDS
Bellevue, Washington, United States
Seattle Children's Hospital - PIN; Investigational Drug Services
Seattle, Washington, United States
Holland Bloorview Kids Rehabilitation Hospital; Autism Research Centre
East York, Ontario, Canada
Gartnavel Royal Hospital; Mental Health & Wellbeing
Glasgow, , United Kingdom
Kings College London
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-003524-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP40331
Identifier Type: -
Identifier Source: org_study_id
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