Clinical Trial: Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of STX209 (Arbaclofen) in Subjects With Autism Spectrum Disorders

Brief Summary: 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.

Detailed Summary:

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. Evaluate the safety and tolerability of long term use of STX209 (Arbaclofen)
  2. Provide supporting pharmacokinetic analyses
  3. Assess long term efficacy on social behaviors in subjects with ASD.

Sponsor: Seaside Therapeutics, Inc.

Current Primary Outcome: Safety and tolerability of STX209 [ Time Frame: 100 weeks ]

Spontaneously-reported adverse events, physical examination, and clinical laboratory assessments


Original Primary Outcome: Same as current

Current Secondary Outcome: Aberrant Behavior Checklist [ Time Frame: 100 weeks ]

Open-label assessment of change from baseline on the ABC


Original Secondary Outcome: Same as current

Information By: Seaside Therapeutics, Inc.

Dates:
Date Received: October 10, 2012
Date Started: November 2011
Date Completion: July 2013
Last Updated: July 30, 2013
Last Verified: July 2013