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There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily [BID], 10 mg BID or 10 mg three times daily [TID]) or placebo. Efficacy,safety and tolerability assessments will be performed periodically
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STX209 5 mg BID | Active Comparator |
| |
| STX209 10 mg BID | Active Comparator |
| |
| STX209 10 mg TID | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arbaclofen | Drug | 5 mg bid |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Behavior Checklist-Lethargy Social Withdrawal subscale | This is a single subscale of the aberrant behavior checklist entitiled Lethargy Social Withdrawal | at 8 weeks of treatment |
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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 | ||
| Miller Children's Hospital |
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| arbaclofen | Drug | 10 mg bid |
|
|
| arbaclofen | Drug | 10 mg tid |
|
|
| Placebo | Drug | tid |
|
| Long Beach |
| California |
| 90806 |
| United States |
| University of California-Davis, M.I.N.D. Institute | Sacramento | California | 95817 | United States |
| Psychiatric Centers at San Diego | San Diego | California | 92108 | United States |
| University of Colorado Denver, Children's Hospital | Aurora | Colorado | 80045 | United States |
| University of Miami, Mailman Center for Child Development | Miami | Florida | 33136 | United States |
| Lake Mary Pediatrics | Orange City | Florida | 32763 | United States |
| Emory University School of Medicine | Decatur | Georgia | 30033 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Kansas University Clinical Research Center | Fairway | Kansas | 66205 | United States |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01605 | United States |
| Children's Hospital of Michigan | Detriot | Michigan | 48201 | 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 |
| New York State Institute for Basic Research in Developmental Disabilities | Staten Island | New York | 10314 | United States |
| Duke Clinical Research Unit | Durham | North Carolina | 27710 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| University of Oklahoma, Physician's Child Study Center | Oklahoma City | Oklahoma | 73117 | United States |
| Suburban Research Associates/Elwyn Genetics | Media | Pennsylvania | 19063 | United States |
| Greenwood Genetics Center | Greenwood | South Carolina | 29646 | United States |
| Vanderbilt Kennedy Center | Nashville | Tennessee | 37203 | United States |
| Childrens Medical Center Dallas | Dallas | Texas | 75235 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | 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 |
|---|---|
| D005600 | Fragile X Syndrome |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D040181 | Genetic Diseases, X-Linked |
| D020271 | Heredodegenerative Disorders, Nervous System |
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| ID | Term |
|---|---|
| C543531 | arbaclofen placarbil |
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