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This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.
This is an open label extension study enrolling by invitation only to those subjects that have completed Seaside protocols 209AS208 and 22007.
Protocol 209AS208, "A Randomized,Double-Blind, Placebo-Controlled, Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects with Autism Spectrum Disorders."
Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."
This open-label extension will provide data on the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STX209 | Experimental | Active treatment with STX209 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STX209 (arbaclofen) | Drug | Long-term, daily, orally-administered STX209 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of STX209 | Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments | 100 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Behavior Checklist | Open-label assessment of change from baseline on the ABC | 100 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Wang, M.D. | Seaside Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Autism Research & Resource Center | Phoenix | Arizona | 85006 | United States | ||
| University of California-Los Angeles Neuropsychiatric Institute |
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| Los Angeles |
| California |
| 90024 |
| United States |
| UCDavis M.I.N.D Insitute | Sacramento | California | 95817 | United States |
| Pharmax Research Clinic | Miami | Florida | 33126 | United States |
| Lake Mary Pediatrics | Orange City | Florida | 32763 | United States |
| Institute for Behavioral Medicine | Smyrna | Georgia | 30080 | United States |
| Institute for Juvenile Research | Chicago | Illinois | 60608 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01605 | United States |
| University of Missouri, Thompson Research Center for Autism & Neurodevelopmental Disorders | Columbia | Missouri | 65211 | United States |
| Seaver Autism Center, Mount Sinai Medical Center | New York | New York | 10029 | United States |
| NYS Institute for Basic Research in Developmental Disabilities | Staten Island | New York | 10314 | United States |
| UNC Chapel Hill Department of Psychiatry | Chapel Hill | North Carolina | 27514 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Cutting Edge Research | Oklahoma City | Oklahoma | 73116 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Tennessee Medical Group, LeBonheur Children's Hospital | Memphis | Tennessee | 38103 | United States |
| Vanderbilt Kennedy Center | Nashville | Tennessee | 37203 | United States |
| Red Oaks Psychiatry Associates, P.A. | Houston | Texas | 77090 | United States |
| Road Runner Research | San Antonio | Texas | 78258 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98101 | 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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