A Phase 3 interventional study of STX209 (arbaclofen) in Autism Spectrum Disorders, sponsored by Seaside Therapeutics, Inc.. Terminated at 25 sites in United States. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2013-07-31.
Sponsored by Seaside Therapeutics, Inc. · Phase 3, Interventional, and Treatment
This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.
This is an open label extension study enrolling by invitation only to those subjects that have completed Seaside protocols 209AS208 and 22007.
Protocol 209AS208, "A Randomized,Double-Blind, Placebo-Controlled, Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Withdrawal in Subjects with Autism Spectrum Disorders."
Protocol 22007, "An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects with Autism Spectrum Disorder."
This open-label extension will provide data on the following:
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's planned enrollment of 165 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Seaside Therapeutics, Inc. is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active treatment with STX209
Drug: STX209 (arbaclofen)
Long-term, daily, orally-administered STX209
Safety and tolerability of STX209
Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
Time frame: 100 weeks
Aberrant Behavior Checklist
Open-label assessment of change from baseline on the ABC
Time frame: 100 weeks
This study is terminated, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Seaside Therapeutics, Inc.