Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders|
- Safety and tolerability of STX209 [ Time Frame: 100 weeks ] [ Designated as safety issue: Yes ]Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
- Aberrant Behavior Checklist [ Time Frame: 100 weeks ] [ Designated as safety issue: Yes ]Open-label assessment of change from baseline on the ABC
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Active treatment with STX209
Drug: STX209 (arbaclofen)
Long-term, daily, orally-administered STX209
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:
- Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)
- Provide supporting pharmacokinetic analyses
- Assess long term efficacy on social behaviors in subjects with ASD.
Show 25 Study Locations
|Study Director:||Paul Wang, M.D.||Seaside Therapeutics, Inc.|