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A Study to Investigate the Efficacy and Safety of RO5285119 in Participants With Autism Spectrum Disorder (ASD)

Conditions

Child Development & Autism

Phase II

What is the purpose of this trial?

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.

  • Trial with
    Genentech, Inc.
  • Start Date
    11/30/2017
  • End Date
    04/17/2019
Trial Image

For more information about this study, contact:

Jane Jurayj

I'm interested in volunteering

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 877.978.8343

  • Last Updated
    01/17/2019
  • Study HIC
    #2000021135