Open-Label Study of the Safety and Tolerability of STX209 in Subjects With Autism Spectrum Disorders

Inclusion criteria

• Male or female subjects 6 to 17 years of age, inclusive.
• Diagnosis of Autistic spectrum disorders
• Clinical Global Impression - Severity (CGI-S) rating for aberrant behavior of moderate or higher at screening and at Visit 1 (Day 1).
• An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score ≥16 at screening and at Visit 1 (Day 1).
• If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 3 months prior to Screening (Visit 1) and subjects and their parent/caregiver/legally authorized representative (LAR) will not electively initiate new or modify ongoing interventions for the duration of the study.
• Exclusion Criteria:
• Subjects with known genetic disorders associated with PDD such as fragile X syndrome.
• Subjects with a history of a seizure disorder who are not currently receiving treatment with antiepileptic medication.
• Subjects with any medical condition, including alcohol and drug abuse that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
• Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
• Subjects currently treated or have been treated in the last 2 weeks with any psychotropic medication except anti-epileptics or who have been treated with fluoxetine in the last 4 weeks.
• Subjects currently treated with vigabatrin or tiagabine.
• Subjects taking another investigational drug currently or within the last 30 days.
• Subjects who have a history of hypersensitivity to racemic baclofen.