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This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are currently participating in Protocol 2202 into a long-term study in which all subjects will receive active drug (arbaclofen).
Three studies sponsored by Seaside Therapeutics, Inc., are currently evaluating the efficacy of STX209 for management of typical problem behaviors in subjects with FXS. These are Study 209FX301, "A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Adolescents and Adults with Fragile X Syndrome;" Study 209FX302, "A Randomized, Double-Blind, Placebo-Controlled, Fixed- Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Children with Fragile X Syndrome;" and Study 22002, "An Open-Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Fragile X Syndrome." This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are currently participating in Protocol 22002 into a long-term, open-label study. The open-label extension protocol will provide data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions reflective of their typical medical care rather than in their previously completed study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arbaclofen | Experimental | Open Label Study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arbaclofen | Drug | A flexible dose titration will be utilized. Orally disintegrating tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Measures | Adverse Events, Suicidality Assessment, Physical Examination, Vital Signs and Weight, Laboratory Tests: Complete Blood Count, Urinalysis, Chemistry Panel | 100 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Aberrant Behavior Checklist Lethargy/Social Withdrawal Sub- Scale Clinical Global Impression Vineland Adaptive Behavior Scales Stanford Binet Intelligence Scale | 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 |
|---|---|---|---|---|---|---|
| Seaside Therapeutics Site #16 | Phoenix | Arizona | 85006 | United States | ||
| Seaside Therapeutics Site #07 |
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| Long Beach |
| California |
| 90806 |
| United States |
| Seaside Therapeutics Site #10 | Sacramento | California | 95817 | United States |
| Seaside Therapeutics Site #17 | Aurora | Colorado | 80045 | United States |
| Seaside Therapeutics Site #01 | Miami | Florida | 33136 | United States |
| Seaside Therapeutics Site #14 | Orange City | Florida | 32763 | United States |
| Seaside Therapeutics Site #20 | Decatur | Georgia | 30033 | United States |
| Seaside Therapeutics Site #02 | Chicago | Illinois | 60612 | United States |
| Seaside Therapeutics Site #23 | Kansas City | Kansas | 66160 | United States |
| Seaside Therapeutics Site #12 | Baltimore | Maryland | 21205 | United States |
| Seaside Therapeutics Site #08 | Worcester | Massachusetts | 01605 | United States |
| Seaside Therapeutics Site #03 | Columbia | Missouri | 65211 | United States |
| Seaside Therapeutics Site #22 | New York | New York | 10029 | United States |
| Seaside Therapeutics Site #04 | Staten Island | New York | 10314 | United States |
| Seaside Therapeutics Site #24 | Chapel Hill | North Carolina | 27514 | United States |
| Seaside Therapeutics Site #21 | Durham | North Carolina | 27710 | United States |
| Seaside Therapeutics Site #05 | Akron | Ohio | 44308 | United States |
| Seaside Therapeutics Site #15 | Oklahoma City | Oklahoma | 73117 | United States |
| Seaside Therapeutics Site #11 | Media | Pennsylvania | 19063 | United States |
| Seaside Therapeutics Site #19 | Nashville | Tennessee | 37212 | United States |
| Seaside Therapeutics Site #25 | Houston | Texas | 77090 | United States |
| Seaside Therapeutics Site #18 | San Antonio | Texas | 78258 | United States |
| Seaside Therapeutics Site #13 | Seattle | Washington | 98121 | 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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