Overview

An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders

Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will enter subjects who complete Study 22003 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with ASD who receive treatment under conditions more closely reflective of their general medical care.
Phase:
Phase 2
Details
Lead Sponsor:
Seaside Therapeutics, Inc.
Treatments:
Baclofen