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

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seaside Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Subject completed study 22007 or 209AS208, and showed he can adequately follow the protocol, and with adequate medical justification to enter this study.

• Parent or other legally-authorized representative or caregiver is willing and able to perform all protocol-specified functions.

• Treatment with no more than 2 psychoactive medications

• Subjects with a history of seizure disorder must be adequately well-controlled, as specified in the study protocol

• For female subjects, negative pregnancy test

Exclusion Criteria:

• Comorbid conditions that might interfere with the conduct of the study or confound the interpretation of the study data, or endanger the subject.

• Current use of illicit drugs or alcohol abuse.

• Subjects with a serious adverse event or other adverse event in study 22007 or 209AS208 that was related to STX209, and that endangers the subject, in the opinion of the investigator

• Current use of another investigational drug, or of vigabatrin, tiagabine, or riluzole