Last updated on November 2017

A Phase II Multi-center, Randomized, Double-blind, 24-Week, 3-Arm, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of RO5285119 in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD)


Brief description of study

A Phase II Multi-center, Randomized, Double-blind, 24-Week, 3-Arm, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of RO5285119 in Children and Adolescents Age 5-17 With Autism Spectrum Disorder (ASD)

Detailed Study Description

This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel group, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of RO5285119 in children and adolescents aged 5-17 years with ASD who are high functioning (intelligence quotient [IQ] greater than or equal to [≥] 70). Enrollment will be staggered, starting first with adolescents (aged 13 to 17 years) and then with children (aged 5 to 12 years). Initially, a first cohort of approximately 24 adolescents will be enrolled together. Based on pharmacokinetic evaluation, safety, and tolerability in the first adolescent cohort and determined final doses, enrollment of adolescents will resume and the enrollment of a first cohort of approximately 24 children (aged 5 to 12 years) can commence. Based on acceptable safety and tolerability in the first children cohort and determined final doses, enrollment of children will resume.

Clinical Study Identifier: TX12195

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Kaley Killdahl

APG Research, LLC
Orlando, FL USA
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