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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Capsules | Placebo Comparator | 1 capsule twice daily |
|
| L1-79 200 mg or 300 mg Capsules | Experimental | 1 capsule twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L1-79 | Drug | tyrosine hydroxylase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Vineland-3 Socialization Domain, Standard Score | Week 12 | |
| V-scale Score for Each of the 3 Socialization Subdomains of the Vineland-3 | Week 12 | |
| Clinical Global Impression of Severity of Illness (CGI-S) Weighted for Socialization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom Megerian, MD, PhD | CMO and Senior VP of Clinical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Autism Research and Resource Center | Phoenix | Arizona | 85006 | United States | ||
| Thompson Autism Center CHOC |
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Two Period Crossover
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| Week 12 |
| Clinical Global Impression of Change (CGI-C) Weighted for Socialization | Week 12 |
| Growth Scale Value (GSV) of Each of the 3 Socialization Subdomains of the Vineland-3 | Week 12 |
| Caregiver Global Impression of Change of 3 Most Bothersome Symptoms of ASD (CGI-3P) | Week 12 |
| Social Responsiveness Scale, Second Edition (SRS-2) Social-Communication and Interaction - DSM-5 Composite T-score | Week 12 |
| Social Responsiveness Scale, Second Edition (SRS-2) Social Awareness T-score | Week 12 |
| Social Responsiveness Scale, Second Edition (SRS-2) Social Cognition T-score | Week 12 |
| Social Responsiveness Scale, Second Edition (SRS-2) Social Motivation T-score | Week 12 |
| Social Responsiveness Scale, Second Edition (SRS-2) Social Communication T-score | Week 12 |
| Social Responsiveness Scale, Second Edition (SRS-2) Total T-score | Week 12 |
| Parent-rated Anxiety Scale for ASD (PRAS-ASD) | Week 12 |
| Aberrant Behavior Checklist, Second Edition (ABC-2) Social Withdrawal/Lethargy Subscale | Week 12 |
| Aberrant Behavior Checklist, Second Edition (ABC-2) Inappropriate Speech Subscale | Week 12 |
| Child's Sleep Habits Questionnaire (CSHQ) | Week 12 |
| Orange |
| California |
| 92868 |
| United States |
| Cortica | San Rafael | California | 94093 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| Thompson Center for Autism and Neurodevelopmental Disorders | Columbia | Missouri | 65211 | United States |
| Center for Autism and The Developing Brain | White Plains | New York | 10032 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Red Oak Psychiatry Associates | Houston | Texas | 77090 | United States |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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