A Multi-center Double Blind Placebo Controlled Study to Assess the Safety and Efficacy of TB006 for Improving Core Symptoms in Adults With Autism Spectrum Disorder
Multisite 14-week prospective double-blind placebo controlled parallel-group randomized clinical trial with 14-week open-label extension at the end of double-blind treatment phase for placebo subjects. Eligible subjects will be randomized within each site in 2:1 ratio to receive either TB006 or placebo treatment.
• Autism Spectrum Disorder as defined below by the ADOS or ADI-R.
• Between 18 and 35 years of age at baseline.
• English included in the languages in which the individual is being raised.
• Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale.
• Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period.
• Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry.
• In males and females of childbearing age, two forms of birth control must be used unless they are not sexually active.
• A caretaker who will accompany the patient to all procedures and has adequate contact with the participant to complete caregiver questionnaires.