Overview
Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders
Status:
Terminated
Terminated
Trial end date:
2013-07-01
2013-07-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
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