This study will investigate the efficacy, safety and tolerability of L1-79 in participants aged 12-21 years who have been diagnosed with ASD with a score of \>/= 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II), and a score of \>/= 4 on the Clinical Global Impression of Severity of Illness (CGI-S) weighted for socialization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
58
tyrosine hydroxylase inhibitor
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States
Thompson Autism Center CHOC
Orange, California, United States
Cortica
San Rafael, California, United States
Rush University
Chicago, Illinois, United States
Vineland Adaptive Behavior Scale, Third Edition (Vineland-3), Responder Analysis
at least 1 point improvement in 2/3 socialization subdomains or at least 3 point improvement in socialization domain
Time frame: Week 12
Vineland-3 Socialization Domain, Standard Score
Time frame: Week 12
V-scale Score for Each of the 3 Socialization Subdomains of the Vineland-3
Time frame: Week 12
Clinical Global Impression of Severity of Illness (CGI-S) Weighted for Socialization
Time frame: Week 12
Clinical Global Impression of Change (CGI-C) Weighted for Socialization
Time frame: Week 12
Growth Scale Value (GSV) of Each of the 3 Socialization Subdomains of the Vineland-3
Time frame: Week 12
Caregiver Global Impression of Change of 3 Most Bothersome Symptoms of ASD (CGI-3P)
Time frame: Week 12
Social Responsiveness Scale, Second Edition (SRS-2) Social-Communication and Interaction - DSM-5 Composite T-score
Time frame: Week 12
Social Responsiveness Scale, Second Edition (SRS-2) Social Awareness T-score
Time frame: Week 12
Social Responsiveness Scale, Second Edition (SRS-2) Social Cognition T-score
Time frame: Week 12
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Thompson Center for Autism and Neurodevelopmental Disorders
Columbia, Missouri, United States
Center for Autism and The Developing Brain
White Plains, New York, United States
Ohio State University
Columbus, Ohio, United States
Red Oak Psychiatry Associates
Houston, Texas, United States
Social Responsiveness Scale, Second Edition (SRS-2) Social Motivation T-score
Time frame: Week 12
Social Responsiveness Scale, Second Edition (SRS-2) Social Communication T-score
Time frame: Week 12
Social Responsiveness Scale, Second Edition (SRS-2) Total T-score
Time frame: Week 12
Parent-rated Anxiety Scale for ASD (PRAS-ASD)
Time frame: Week 12
Aberrant Behavior Checklist, Second Edition (ABC-2) Social Withdrawal/Lethargy Subscale
Time frame: Week 12
Aberrant Behavior Checklist, Second Edition (ABC-2) Inappropriate Speech Subscale
Time frame: Week 12
Child's Sleep Habits Questionnaire (CSHQ)
Time frame: Week 12