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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
357
A flexible dose titration will be utilized. Orally disintegrating tablets
Seaside Therapeutics Site #16
Phoenix, Arizona, United States
Safety Measures
Adverse Events, Suicidality Assessment, Physical Examination, Vital Signs and Weight, Laboratory Tests: Complete Blood Count, Urinalysis, Chemistry Panel
Time frame: 100 weeks
Efficacy
Aberrant Behavior Checklist Lethargy/Social Withdrawal Sub- Scale Clinical Global Impression Vineland Adaptive Behavior Scales Stanford Binet Intelligence Scale
Time frame: 100 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Seaside Therapeutics Site #07
Long Beach, California, United States
Seaside Therapeutics Site #10
Sacramento, California, United States
Seaside Therapeutics Site #17
Aurora, Colorado, United States
Seaside Therapeutics Site #01
Miami, Florida, United States
Seaside Therapeutics Site #14
Orange City, Florida, United States
Seaside Therapeutics Site #20
Decatur, Georgia, United States
Seaside Therapeutics Site #02
Chicago, Illinois, United States
Seaside Therapeutics Site #23
Kansas City, Kansas, United States
Seaside Therapeutics Site #12
Baltimore, Maryland, United States
...and 13 more locations