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Keep this study
Lead
University of California, Los Angeles
Age
18–35
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Subjects with a diagnosis of ASD as defined by DSM-5, confirmed by clinical evaluation and supported by the Autism Diagnostic Observation Schedule (ADOS)
Ages 18- 35 years inclusive
IQ estimate of \>80
Aberrant Behavior Checklist (ABC)-Social Withdrawal Score \>10 (\>40% over population mean for developmentally disabled adults)
Existing allowed concomitant medication treatment stable for the 8 weeks prior to study entry, and no anticipated changes
Ability to comply with all protocol procedures and assessments
Availability of a reliable parent or caregiver willing to provide information regarding subject behavior and health status
Evidence of EEG biomarker deficit as defined below.
You may not be if
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
Clareo Health | Targeting GABA-A for the Treatment of Social Disability in Young Adults With Autism Spectrum Disorders: A Phase II Proof of Mechanism Trial
