Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject meets the DSM-5 criteria for ASD for an autism diagnosis and is confirmed using ADOS-2 criteria
SRS-2, proxy version, total t-score \>=66 at screening
A full scale IQ score \>=70 on the WASI®-II
Subject has an appropriate study partner, in the opinion of the investigator
For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of \<1% per year during the treatment period and for at least 28 days after the last dose of study drug
Treatment with permitted medications (at a stable dose for 12 weeks before screening) and behavioral therapy regimens (regimens stable for 6 weeks before screening), with the intent that such treatments remain stable throughout the study and with no expected changes before the Week 24 visit
You may not be if
Pregnancy or breastfeeding, or intention to become pregnant during the study
Previous initiation of new or major change in psychosocial intervention within 6 weeks prior to screening
Unstable or uncontrolled clinically significant affective or psychotic disorders and/or neurologic disorder that may interfere with the assessment of safety or efficacy endpoints
Substance use disorders during the last 12 months
Significant risk for suicidal behavior, in the opinion of the investigator
Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
Clinical diagnosis of peripheral neuropathy
Within the last 2 years, unstable or clinically significant cardiovascular disease
Uncontrolled hypertension
Unexplained syncopal episode within the last 12 months
Confirmed elevation above upper limit of normal of CK-MB, high sensitivity cardiac troponin T, cardiac troponin I, and/or N-terminal pro B-type natriuretic peptide
Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression (including iatrogenic), or current major bleeding event
Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or what would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Confirmed clinically significant abnormality in parameters of hematology
Confirmed clinically significant abnormality in parameters of clinical chemistry, coagulation, or urinalysis
Medical history of malignancy, if not considered cured
