Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
|ClinicalTrials.gov Identifier: NCT01706523|
Recruitment Status : Terminated
First Posted : October 15, 2012
Last Update Posted : July 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Drug: STX209 (arbaclofen)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2013|
Active treatment with STX209
Drug: STX209 (arbaclofen)
Long-term, daily, orally-administered STX209
- Safety and tolerability of STX209 [ Time Frame: 100 weeks ]Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments
- Aberrant Behavior Checklist [ Time Frame: 100 weeks ]Open-label assessment of change from baseline on the ABC
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01706523
|Study Director:||Paul Wang, M.D.||Seaside Therapeutics, Inc.|