Targeting GABA-A for the Treatment of Social Disability in Young Adults With Autism Spectrum Disorders: A Phase II Proof of Mechanism Trial

Exclusion Criteria

• •Evidence of current drug or alcohol abuse or dependence
• •Prior history of drug or alcohol abuse or dependence in prior 12 months
• •History of seizure disorder (except febrile seizures)
• •Clinically significant aggressive, disruptive, or suicidal behavior in the 3 months prior to study enrollment
• •Presence of a chronic medical condition or prohibited medication (see list in Human Subjects section) which would potentially interfere with the assessment of treatment effects, or interact with study medications (eg. hepatic, neurologic, renal disease) to increase risk to the subject
• •History of paradoxical reactions to benzodiazepines
• •Clinically significant deviation from the reference range in clinical laboratory test results at screening, as judged by the investigator
• •ALT or AST greater than the upper limit of the laboratory standard reference range at screening
• •EKG abnormalities considered to be clinically significant as determined by the investigator and confirmed by an experienced cardiologist
• •Fredericia-corrected QT (QTcF) interval of \>450 msec
• •Clinical judgment of the study physician of inability to perform the requirements of the study
• •For sexually active female and male subjects, refusal to agree to maintain a double-barrier birth control method during protocol participation