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The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22003 will be offered participation in 22003A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STX209 | Drug | collection of serum for DNA to elucidate a potential biomarker for patients with ASD |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker | evaluation of DNA for ASD to elucidate a potential biomaker | june 2013 |
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Inclusion Criteria:
Exclusion Criteria:
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Autism Spectrum Disorder subjects
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| Name | Affiliation | Role |
|---|---|---|
| Craig Erikson, MD | Riley Hospital for Children | Principal Investigator |
| Bryan King, MD, PhD | Seattle Children's Hospital | Principal Investigator |
| James McCracken, MD | University of California, Los Angeles | Principal Investigator |
| Lawrence Scahill, PhD | Yale University | Principal Investigator |
| Linmarie Sikich, MD | University of North Carolina Neurosciences Hospital | Principal Investigator |
| Jeremy Veenstra-VanderWeele, MD | Vanderbilt Kennedy Center | Principal Investigator |
| Lawrence Ginsberg, MD | Red Oaks Psychiatry Associates, PA | Principal Investigator |
| Raun Melmed, MD | Southwest Autism Research & Resource Center | Principal Investigator |
| 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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| ID | Term |
|---|---|
| D005600 | Fragile X Syndrome |
| ID | Term |
|---|---|
| D038901 | X-Linked Intellectual Disability |
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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DNA from blood, plasma
| Los Angeles |
| California |
| 90024 |
| United States |
| Yale Child Study Center | New Haven | Connecticut | 06520 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| University of North Carolina Neurosciences Hospital | Chapel Hill | North Carolina | 27514 | United States |
| Vanderbilt Kennedy Center | Nashville | Tennessee | 37203 | United States |
| Red Oaks Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98101 | United States |
| 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 |