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A Multi-Center, Randomized, Double-Blind, 12-Week, Parallel Group, Placebo-Controlled Proof of Concept Study to Investigate the Efficacy and Safety of RO5285119 in Individuals with Autism Spectrum Disorders (ASD)
The main objective of this study is to evaluate the efficacy of 12-week treatment with RO5258119 compared with placebo in treating social communication deficits in adult individuals with ASD as measured by the social responsiveness scale (SRS) as well as to evaluate the safety and tolerability of 12-week treatment with RO5258119 in adult individuals with ASD
The study will be conducted in two stages:
• In Stage 1, subjects will be randomized to receive either 5 mg/d of RO5285119 or placebo based on an allocation ratio of 2:1. After at least 12 subjects (8 on RO5285119 / 4 on placebo) have completed at least 6 weeks of treatment, a safety interim analysis of all available safety data will be conducted by a data safety monitoring board (DSMB). If no hematological (or other relevant) safety signal is observed Stage 2 will be initiated.
• In Stage 2, subjects will be randomized to receive either 5 mg/d or 12 mg/d of RO5285119, or placebo using an allocation schedule that will ensure a final allotment in the study of 30 subjects to receive 5 mg/d of RO5285119, 60 subjects to receive 12 mg/d of RO5285119, and 45 subjects to receive placebo. Treatment randomization will be unbalanced (approximately 1:3:2) to gather more information and improve the precision estimate for the 12mg/d RO5285119 treatment arm.
During both stages of the study, the participants will be asked to visit the site for physical and medical exams, blood draws, ECGs, urine tests, as well as behavioral assessments.
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