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The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arbaclofen followed by Placebo |
| ||
| Placebo followed by Arbaclofen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STX209 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in plasma proteins with treatment | After 4 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Fragile x syndrome subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Berry-Kravis, MD, PhD | Rush University Medical Center | Principal Investigator |
| Randi Hagerman, MD | M.I.N.D. Institute | Principal Investigator |
| 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 |
| Jonathan Picker, MBChB, PhD | Boston Children's Hospital | Principal Investigator |
| Linmarie Sikich, MD | University of North Carolina Neurosciences Hospital | Principal Investigator |
| Jeremy Veenstra-VanderWeele, MD | Vanderbilt Kennedy Center | Principal Investigator |
| Ted Brown, MD, PhD | NYS Institute for Basic Research in Developmental Disabilities | 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
| Lawrence Ginsberg, MD | Red Oaks Psychiatry Associates, PA | Principal Investigator |
| Shivkumar Hatti, MD | Suburban Research Associates | Principal Investigator |
| Raun Melmed, MD | Southwest Autism Research & Resource Center | Principal Investigator |
| Los Angeles |
| California |
| 90024 |
| United States |
| M.I.N.D. Institute | Sacramento | California | 95817 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| NYS Institute for Basic Research in Developmental Disabilities | Staten Island | New York | 10314 | United States |
| University of North Carolina Neurosciences Hospital | Chapel Hill | North Carolina | 27514 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | 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 |